Washington Post Staff Writer
Wednesday, June 19, 2002; Page A01
Antibiotic prescriptions for children fell by 40 percent over the course of
the 1990s, reversing an upward trend that had fueled the emergence of
hard-to-treat, drug-resistant bacteria, researchers reported yesterday. The
dramatic reversal was seen across the spectrum of common ailments of
childhood, including ear infections, sore throats, bronchitis and
miscellaneous respiratory infections. It was seen in all ways that drug
prescribing is gauged -- total number of prescriptions, prescriptions per
child and prescriptions per trip to the doctor.
The change follows numerous public health campaigns aimed at doctors and
parents, widespread media coverage of "super-bugs" and a few documented
examples of death from bacterial infections that once would have been easily
"It's a dramatic decline," said Linda F. McCaig, an epidemiologist at the
National Center for Health Statistics, the organization that regularly
surveys the prescribing behavior of American physicians. "It's encouraging
that parents and physicians may be getting the message about how to use
The national survey results appear in today's Journal of the American
Medical Association. Accompanying them is a report on a successful 1997
campaign to lower antibiotics use in Knoxville, Tenn., the American city
with the highest per capita use of prescription drugs in the country.
That campaign featured a number of strategies, including lectures to doctors
and handouts to parents of newborns. It produced a drop in antibiotic
prescription-writing over the next two years that was more than double that
seen in three other Tennessee cities -- 19 percent vs. 8 percent.
"We think this can serve as a model for community-wide interventions in
other places," said Allen S. Craig, Tennessee's state epidemiologist.
Neither the national nor the local study measured the effects on children's
health -- good or bad, or none at all -- from the decline in antibiotic use.
However, in Knox County (Knoxville and its suburbs), there was no increase
in serious infections from Streptococcus pneumoniae -- the most common
bacterial pathogen in young children -- said Stephanie Hall, the county
health officer. There also wasn't a decrease in the prevalence of
drug-resistant strains of the bacterium, although that is likely to take
longer to occur.
Most antibiotics used in the United States are prescribed in doctor's
offices. Usually they are for infections for which the practitioner isn't
certain what microbe is responsible.
The proliferation of antibiotics, and the cultural perception that taking
them is the safer course in situations of uncertainty, has led to a steady
their use over the last 30 years, peaking in 1992. At that time, American
children under age 15 got, on average, one antibiotic prescription a year.
Many studies have shown, however, that when definitive diagnostic tests are
performed, most upper respiratory infections are caused by viruses, not
bacteria. Viruses are not killed by antibiotics.
Several experts said it is unclear whether the decline seen in the two
studies will last. "We know from the experience in other countries that when
you are on top of things, you can control prescribing," said Stuart B. Levy,
a physician at Tufts University School of Medicine, who founded the Alliance
for Prudent Use of Antibiotics in 1981. "But once you leave, there's a great
temptation to go back to the old behavior. So, reminders will be needed."
In the National Ambulatory Medical Care Survey, about 3,000 office
practitioners are asked to record patient visits, and what they prescribe,
for a week. The sample is chosen to represent the country statistically.
In the 1989-1990 survey, the average annual number of antimicrobial drugs
prescribed in offices to children under age 15 was 45.5 million. In
1999-2000, it was 30.3 million. The rate of prescription per 1,000 visits
fell from 838 to 503 -- a decrease of 40 percent. The rate at which trips to
the doctor by children resulted in antibiotic prescriptions fell from 330
per 1,000 visits to 234 per 1,000 visits -- a decrease of 29 percent.
This last measure is the best window on what is happening in the doctor's
office -- where a complicated interaction of the patient's ailment, the
physician's judgment and knowledge, and the parent's expectation determines
behavior, McCaig said.
The Knoxville campaign began after three children in a day-care center in
nearby Morristown developed meningitis caused by multi-drug-resistant S.
pneumoniae in one week in 1996. One died.
A physician from the Centers for Disease Control and Prevention was invited
to talk to 150 key physicians in Knox County. Prescribing guidelines were
sent to 250 doctors, 40,000 pamphlets were given to parents of toddlers and
young grade-schoolers, and 53,000 pamphlets were handed out to pharmacy
© 2002 The Washington Post Company
a. The number of physicians in the US is 700,000.
b. Accidental deaths caused by Physicians per year is 120,000.
c. Accidental deaths per physician is 0.171. (US Dept. of Health & Human
Then think about this:
a. The number of gun owners in the US is 80,000,000.
b. The number of accidental gun deaths per year (all age groups) is 1,500.
c. The number of accidental deaths per gun owner is .0000188.
Statistically, doctors are approximately 9,000 times more dangerous than
FACT: NOT EVERYONE HAS A GUN, BUT ALMOST EVERYONE HAS AT LEAST ONE DOCTOR.
When Modern Medicine Fails
By Charles Krauthammer
Friday, July 12, 2002; Page A21
In "Sleeper," Woody Allen wakes up a couple of hundred years in the future
to discover, among other things, that scientists have found that tobacco is
actually good for you.
Well, not quite yet. But how about eggs? After years of egg phobia, we have
learned that eggs may not be bad for you after all. And that butter is
healthier than stick margarine. Every month, it seems, some accepted
nutritional fact is overturned.
We have come to expect that diet fashions, though promulgated with
scientific authority, change like the seasons. What we do not expect is a
change in hormone fashions. Hence the shock this week when a massive study
of hormone replacement therapy in postmenopausal women had to be halted
three years early because the estrogen-progestin combination appeared to
cause an alarming increase in invasive breast cancer, blood clots, strokes
and heart attacks.
With that, the decades-old medical axiom about the protective powers of
hormonal therapy was overturned in a flash. The reverberations were
immediate. The company whose pill was being tested, Wyeth Pharmaceutical,
lost 24 percent of its value in one day. Millions of women are now
frantically calling their doctors for advice on whether to continue.
Most shocking, perhaps, is the simple reminder of how contingent are the
received truths of modern medicine. We know how pre-modern medicine got it
wrong, from centuries of leeching and bleeding to the lobotomies and shock
therapies that destroyed the lives of so many psychiatric patients in the
mid-20th century. But we think of modern science as infinitely more
enlightened and more solid.
Not so. Less than a century ago, the most exalted scientific theory,
Newtonian mechanics, was overthrown. Today its successors, general
relativity and quantum mechanics, have yet to be fully reconciled. Thirty
years ago, the scientific consensus was that we were headed for global
cooling. Today it is global warming. The only thing I feel reasonably sure
about is that 30 years from now meteorological science will have delivered
yet a new theory, a new threat, a new thrall.
The problem is that even the most sophisticated scientific studies are
limited by method, by modeling, by sampling and by an inevitable margin of
error. Hence error and revision. In medicine, because its solemn
pronouncements are so widely propagated and so ingrained in people's lives,
these revisions are particularly shocking. Yet common. When I was a kid,
everyone got a tonsillectomy. It was a rite of passage. We now know that
this was unnecessary surgery, indeed, worse than useless. We also routinely
were given antibiotics for earaches. It now turns out that this did not
hasten recovery, and in fact may have made us, and the population in
general, more resistant to antibiotics.
For decades, breast cancer was treated with radical mastectomy, a
disfiguring and deeply invasive surgery. The idea that many patients should
instead be treated with lumpectomy was ridiculed for decades. It is now
accepted medical practice. My favorite myth is 98.6. If there was anything
solid in my medical education, it was that mean body temperature was 98.6 F.
Well, in 1992 the Journal of the American Medical Association published a
study that actually measured it. It turns out to be 98.2 degrees. Where did
the 98.6 come from? From the German doctor, Carl Wunderlich. In 1868. No
one had bothered to check it since then.
The myths go on and on. That infectious diseases had been conquered. (Then
came HIV.) That asthma is a psychological condition. That ulcers are caused
by stress or stomach acid. For decades at mid-century, at the height of the
psychoanalytic fad, the cream of the New York intelligentsia was sending its
healthy children to five-day-a-week psychoanalysis.
So much nonsense. So much damage. Yet science has a hard time with humility.
The rage today is regenerative medicine. Stem cells. Cloning. The growing,
essentially, of replacement parts. It sounds wonderful, and it may yet turn
out to be.
It is well to remember, however, that this is not the first panacea to be
peddled. Yesterday, it was fetal tissue transplants for degenerative
diseases and angiogenesis inhibitors for the cure of cancer. All of which
looked wonderful on paper but have not panned out. This is not to say that
this embryonic research will not pan out. It is only to say that when you
hear Sen. Dianne Feinstein tell you that the research cloning her bill would
promote will do wonders for your suffering Aunt Sarah, hold on to your
wallet. She's talking about the speculative benefits from the most
speculative of new technologies --at a time when, until yesterday, science
could not tell us the effects of existing postmenopausal hormone therapy on
known medical conditions. For now, I'll put my money on Woody Allen.
"Sleeper" discovers that hot-fudge sundaes turn out to be good for you too.
© 2002 The Washington Post
NEW YORK (Reuters Health) Oct 07 - One in 10 children who are treated in the
emergency department (ED) may get the wrong dose of medicine or be given
medication at the incorrect frequency, new study findings suggest.
Children seen between 4 AM and 8 AM, children with severe disease and those
seen on weekends were between 1.5 and 2.5 times more likely to experience a
medication prescribing error than others, lead author Dr. Eran Kozer, from
the Hospital for Sick Children in Toronto, and colleagues note.
In their paper in the October issue of Pediatrics, Dr. Kozer and colleagues
note that between 44,000 and 98,000 people die each year in the US as a
result of medical errors. And prescribing errors, they note, occur most
frequently in pediatric patients and EDs.
Dr. Kozer's team reviewed the medical records of 1532 children treated in
the ED of a pediatric hospital. Two pediatricians independently decided
whether a medication error had occurred and gave errors a numerical severity
"Prescribing errors were identified in 10.1% of the charts," the researchers
"The most common types of prescribing errors were dosing errors, followed by
drugs given with incorrect frequency," they add.
Drugs most commonly implicated in prescribing errors included acetaminophen,
antibiotics, asthma medications and antihistamines.
"Our findings suggest that errors are more common among seriously ill
patients and that trainees are more likely to make medical errors,
particularly at the beginning of the academic year," the authors write.
"Future research should focus on the development and evaluation of
strategies to reduce medication errors in the pediatric emergency
department," they conclude.
Annu. Rev. Public Health 2002. 23:135-150.
MORBIDITY AND MORTALITY FROM MEDICAL ERRORS: An
Increasingly Serious Public Health Problem
David P. Phillips and Charlene C. Bredder
From 1983 to 1998, U.S. fatalities from acknowledged prescription errors
increased by 243%, from 2,876 to 9,856. This percentage increase was greater
than for almost any other cause of death, and far outpaced the increase in
the number of prescriptions. Many nonfatal prescription errors also occur,
but estimates of the frequency of these errors vary widely, because various
definitions, geographic settings, and institutions have been used. Efforts
to reduce fatal and nonfatal prescription errors have encountered
perceptual, legal, medical, and cultural barriers. It may be possible to
reduce prescription errors by instituting a central agency responsible for
collecting, analyzing, and reporting harmful or potentially harmful drug
events, and for issuing recommendations and directives.
GANGSTERS IN MEDICINE
By Thomas Smith
December 23, 2002
The Journal of the American Medical Association recently reported that as
many as 106,000 deaths occur annually in US hospitals due to adverse
reactions to prescription drugs that are properly prescribed by physicians
that use them as directed by the drug companies. Even worse, the National
Council for Patient Information and Education reported that an additional
125,000 deaths occur annually due to adverse reactions to drugs that the
physician never should have prescribed. In these deaths the doctor did not
follow the instructions on proper administration of the drugs. For example,
Glucophage, a diabetic oral hypoglycemic, should never be prescribed for
patients with Kidney disease or Congestive Heart Failure because it can
cause fatal Lactic Acidosis in these patients. A warning label is
prominently placed on the medication container to warn of this potential
However, JAMA reported that almost 1/4 of the patients who had been
prescribed Glucophage had Kidney damage or Congestive Heart failure or both.
The annual death toll from synthetic prescription drugs, both from the
correctly prescribed and the incorrectly prescribed, amounts to about
231,000 deaths every year. To put this into perspective, this is the
equivalent of a world trade center disaster every week for over a year and a
half or the crash of two fully loaded 747 aircraft every day of the year.
No information was reported on the number of outpatient and doctor's
office deaths caused by these very same drugs when prescribed by these very
same doctors. The reported figures alone, however, make drug deaths caused
by physicians the third leading cause of death in the US. It is far ahead of
accidents, drunk driving, homicides, airline accidents, as well as all other
disease with the sole exceptions of cancer and heart disease. Many of these
drugs responsible for the death statistics cited are diabetic drugs. None of
these drugs cure or even were intended to cure diabetes.
During the time a patient is on the drugs his body is suffering great damage
due to the uncontrolled progress of the disease. This is in addition to the
risk and damage caused by the drug itself.
According to Dr. Mendelsohn, author of "Confessions of a Medical
Heretic", 2.4 million unnecessary operations are performed every year and
they cost over 12,000 lives. When the records of six New York hospitals were
examined it was found that 43% of the Hysterectomies that were performed
were medically unnecessary. No one should ever submit to any surgical
procedure without first obtaining several unrelated medical opinions, at
least not here in the United States. Women are particularly vulnerable to
this type of victimization.
Disease in America
According to the World Health Report 2000 the United States ranks
twelfth, that is second from the bottom, in their thirteen country survey of
sixteen available health indicators. We are dead last for low birth weight
and neonatal and infant mortality. We rank between ninth and twelfth for all
life expectancy categories between one year and 40 years. Another study
ranked the United States as fifteenth in the twenty-five industrialized
Diabetes, Hypoglycemia, Hyperinsulinemia are so widespread in the United
States that it is estimated that over half the population exhibits one or
more symptoms of these life destroying diseases. Symptoms of Adult onset
diabetes are now being routinely noted in six year old children. Obesity and
it's related Endocrine dysfunction are commonly observed in teenagers.
Heart Failure, a symptom of advanced Type II Diabetes, remains in the top
three killer diseases in the Westernized countries. Although the cause and
cure for Type II Diabetes and related endocrine failure has been
increasingly well understood in the scientific community for the last forty
years, this disease is not being cured by todays orthodox treatment
regimens. In order to find a cure it is necessary to seek alternative
medical approaches to this disease.
Some of the economics of Medicine
A large part of this medical disaster that the United States currently
experiences is due to the way our medical community is organized. Basically
it is not organized to heal and to cure disease; the medical community,
particularly at its upper levels, is a commercial venture organized to make
money for its practitioners.
Although the record of the United States Medical community in the cure
of disease is deplorable, the same cannot be said for its ability to produce
income and profit. For example, for the top fifteen pharmaceutical
companies, including such names as Abbot, Wyeth, Hoffman-La Roche, Merck and
others, the second quarter revenue for 2002 was reported as $63,520.6
million and the corresponding reported income was 11,731.8 million
respectively. This is second only to the defense industry in the United
States. In 1997, the latest year for which we have the figures, the
earnings of physicians were reported by Broad as averaging around $200,000
per year. The lowest reporting specialty, Rheumatology reported $158,500 and
the highest, cardiovascular surgeon, reported $363,300. When examining the
numbers, we noted that the high salaries seemed to be concentrated in
members of the AMA. Those belonging to less powerful trade unions did not
fare nearly so well even though they did most of the actual patient care
work. For example, the median staff salary of registered nurses was $35,256
The Cardiac surgeon, for example, does nothing whatsoever to cure
cardiac disease. Three to five percent of the heart surgery patients die on
the operating table. Cardiac surgery provides no better three year survival
rate than no treatment at all. A Harvard survival study of 200,000 patients
revealed that the long term survival rate of patients subjected to surgery
was no better than the survival rate of those that had no surgery. Of
course, your cardiac surgeon will not tell you this when you need to make a
decision on whether or not to elect cardiac surgery. Never in history have
so many accumulated so much wealth for providing their customers or clients
or patients with so little real benefit.
Exceptions to the rule
Many doctors of integrity are as much victims of the system as are their
patients. Todays doctor is not free to treat disease as his conscience
dictates. He is forced to administer approved protocols whether they are
known to work or not. To deviate from these approved protocols invites law
suits, peer criticism and censure from State medical licensing boards. This
writer knows of two local doctors who tried to buck the establishment and
really help their patients. Both lost their license to
practice medicine. One is currently working as an administrator in a
California hospital and the other has started a nutritional clinic.
Takeover of the American medical Association
This sad state of affairs is directly traceable to the takeover of the
American Medical Association by the Carnegie and Rockefeller foundations in
the early part of the twentieth century. At the turn of the century the
medical community was in a sad state of disrepair. There were no
qualifications to become a doctor. If one wanted to be a doctor it was only
necessary to hang out a shingle and start the practice of medicine. Medical
schools were poorly financed, often taught contradictory medical
philosophies and had little impact on the practice of medicine. In 1910 the
American Medical Association, todays AMA, was on the verge of bankruptcy.
Few doctors belonged to it and even fewer paid any attention to it. Quackery
of all kinds was rampant. The market was flooded with fake cancer cures and
80 proof liver tonic.
It was in this environment that Rockefeller and Carnegie moved in and
bought the AMA and then used it to take control of the entire United States
medical establishment. In 1910, Henry Prichard president of the Carnegie
foundation, bought control of the AMA for the sum of $10,000. He then
financed the publication of the Flexner report, as it was then called, to
gain popular support for the changes that were to be made in the medical
community. With public backing secured by the publication of the Flexner
report, Carnegie and Rockefeller commenced a major upgrade in medical
education by financing only those medical schools that taught what they
wanted taught. Predictably, those schools that had the financing churned out
the better doctors.
In return for the financing, the schools were required to teach course
material that was exclusively drug oriented. That is why today our doctors
are so heavily biased toward synthetic drug therapy and know little or
nothing about nutrition. Dr. David Edsall, former dean of Harvard medical
school, said "I was, for a period, a professor of Therapeutics and
Pharmacology, [at Harvard] and I knew from experience that students were
obliged then by me and by others to learn about an interminable number of
drugs, many of which were valueless, many of them useless, some probably
For a time, these changes actually improved the practice of medicine in
the United States. Then, as the distorted medical curriculum began to churn
out doctors whose only concern was prescribing synthetic drugs, things began
to deteriorate into what we see today. Today the average medical doctor
receives 3 hours or less training on nutrition despite the fact that our
bodies are constructed entirely of what we eat and drink. Todays doctor
receives much of his ongoing education from detail men. The detail man is
the drug company salesman whose job it is to teach the doctor how to use the
Treatment instead of cure
Even with all of this history the medical doctor
retained a great deal of his autonomy through the 1930's and into the late
1940's. In 1949 another major change took place in the medical community
that set the stage for the disaster we see today. It was in 1949 that the
medical community reorganized itself into the competing medical specialty
groups we see today. Prior to 1949 a doctor was a doctor; he dealt with all
disease and injury. After 1949 this was not so. The reorganization
established many of the specialties that we know today. It was then that the
Cardiac Specialist, the Endocrinologist, the Hepatic and Biliary Specialist
and many other professional specialty groups were formed. The symptoms of
the then raging epidemic of Type II Diabetes were divided among the
specialty groups so that each group had their own set of proprietary
The story given out for the reorganization was that it would help to focus
more attention on the then current Diabetes epidemic. However, in practice
it caused the entire medical community to treat their own proprietary
symptom set and nobody focused on curing the disease anymore. This was the
origin of the "treat the symptom" and "ignore the cause" philosophy that now
dominates the entire medical community. This was the turning point event
that led to the removal of the word "cure" from the medical vocabulary.
Today, if you mention the "c" word around your doctor he will usually glaze
over and pretend not to hear you. He only responds to the word
Under the Rockefeller and Carnegie influence their pharmaceutical firms
started to pour out the vast array of synthetic drugs that the doctors
trained to their medical school standards now prescribed almost to the
exclusion of any other remedies. Among the first drugs to be marketed this
way were the oral hypoglycemic agents. They were deliberately designed to
treat the symptom while not curing the disease.
Since the name of the medical game was money, a means had to be devised to
provide the patient with money that could only be used to pay for approved
medical treatment. Enter the insurance company concept. Today employees
have, as an important part of their remuneration for their work, a health
insurance policy. This health insurance policy does not pay for all health
related needs; it only pays for those health related services that are
approved. These, of course, are the synthetic drug therapies that are known
to work poorly, if at all. In order to secure effective medical treatment
from the alternative sector ofthe economy the patient must pay for it
himself; insurance companies specifically exclude virtually all alternative
treatment. One wonders why so many continue to pay for an insurance program
that cannot, even in principle, be of any real benefit to them.
Government coercion in medical practice
In the ordinary course of events, good medicine would eventually drive out
bad medicine. As more and more people discover ways to maintain and improve
their health, without drug therapy, they will simply abandon bad medicine
and resort to alternative therapies. Indeed, this is happening. Also
happening is a concerted government effort to discredit and declare unlawful
those effective therapies that represent the greatest threat to orthodox
medicine. In the last fifty years many effective cures have been developed
for many of the major killer diseases that we have. In each instance the
developer has been branded a quack, his business has been ruined and in some
cases he has been sent to jail.
Even with outright governmental attacks on those that would promote
effective therapies in America, the tide is turning. More and more Americans
are waking up to the reality of our medical community. More and more they
are finding it to be a fraud and they are turning to less conventional
treatments and modalities. Informed Americans that require effective
medical treatment for anything more serious than a head cold are turning
away from orthodox drug quackery in droves. The medical community is trying
hard to make it illegal to refuse their treatment. A major effort is
currently underway (Codex) to severely restrict the availability of
nutritional supplements to those that use them throughout the world. Our
government is seriously considering mandatory vaccination programs.
Many believe that our Food and Drug Administration, FDA, represents the
American people and that the FDA acts to insure that our food and drugs are
safe and effective. Nothing could be further from the truth. The FDA acts
entirely to restrain and manage competition between and among those that
manufacture our food and drugs. They do this only for the purpose of
minimizing competition in business. Rockefeller is famous for proclaiming
the only sin is competition. Willy Ley, a former head of the FDA, said it
best when he said "What the Food and Drug Administration does and what the
public thinks that it does are a different as night and day".
Today in America the practice of medicine is not free. It is one of the
most tightly controlled commercial enterprises in the world. That is why it
produces such extraordinary income for it's favored and such misery, disease
and death for its victims.
What to do
Given the growth of the medical monster that ate the United States, what can
we who live here do to effectively manage our own health. Perhaps the single
most important thing that we all must do is to recognize that our health is
our most important possession. We have no choice but to accept total
responsibility for our own health. To leave such an important consideration
to someone who clearly has much to gain by lying to us just does not make
sense. Typically, we buy our cars and houses with a great deal more wisdom
than we bring to the doctor's office when we go there. The modern
orthodox medical community treats symptoms; they do not cure disease. When
you visit the doctor, it is perfectly in order for you to ask bluntly
whether or not the treatment he wants to give you will cure the disease you
have. Some years ago, when I had a serious case of Type II Diabetes, I
asked my doctor that question about the treatment he offered me. First he
pretended he did not hear me. When I persisted and made eye contact and
repeated the question he replied "this is the prescribed treatment". Such an
evasive answer to such a direct question sent me to the library where I did
the research to get a better answer. I quickly discovered that the drug he
offered me would not only not cure the disease, but that it was guaranteed
to put me on the road to becoming an invalid long before my time.
Fortunately I rejected his treatment. I went on to search the scientific
literature where I quickly found what I needed. It had nothing to do with
synthetic drugs. It took me about 3 1/2 months to fully reverse my diabetes.
That was seven years ago. The disease remains in full remission to this
There is one important caveat that must be mentioned
at this point. If you are currently under a doctors care and are
dissatisfied with the results you are getting, do not just stop taking the
prescribed medication. Get your doctor, or another doctor if yours will not
cooperate, to help weanyou off prescription drugs and to help you to devise
a workable alternative therapy. Many of these synthetic drugs will produce
serious side effects if they are abruptly discontinued. When I had the
problem I had not yet taken prescription medication.
After accepting full responsibility for your own health, the second most
important consideration is to do your homework and learn about the disease
or disability that you have. Buy books, attend seminars, subscribe to
newsletters, search the internet, learn about what it takes to actually
reverse the disease that afflicts you. Investigate alternative medical
practitioners. Many Naturopaths and Chiropractors can be of great help in
actually curing disease. Do not fall for the idea that only doctors are
smart enough to understand these things. Look for that unusual doctor that
will risk really trying to help you; and, realize that he is taking a
substantial risk when he does so. In other words, do the best you can to
find something better for yourself than what your doctor offers. Help each
other. If you discover something important, don't be afraid to share the
information. Be vocal when government organizations attempt to restrict or
deny your access to natural nutritional supplements.
If you are fortunate to find a doctor with this kind of integrity,
understand the importance of what you have found and give him all of the
support that you can give. There is a medical doctor in California, we will
call him Doctor Q, that refused to compromise his integrity in his practice
of medicine. He ended up in jail, put there by his fellow doctors. His
patients got together, got him out of jail and had a special bill passed in
the State legislature to protect his practice of medicine. Today he still
runs a flourishing practice where he ministers to patients from all over
this country. He is actually curing disease not just treating it.
Third, after accepting responsibility for your own health and becoming
informed, recognize that medicine is a business. Your doctor is a paid
consultant just like your electrician or plumber and he is listed in the
same yellow pages. You have every right to get the information for which you
are paying. When your doctor retreats into arrogance and refuses to provide
direct answers to direct questions, consider getting another doctor. There
really are many safe and effective therapies that go far beyond drugs.
However, we must demand them on the firing line, in the doctor's office,
when we need them.
© 2002 Thomas Smith - All Rights Reserved
Thomas Smith is a reluctant medical investigator having been forced into
seeking a cure for his own Diabetes because it was obvious that his doctor
would not or could not cure it. He has published the results of his
successful Diabetes investigation in his special report entitled "Insulin:
Our Silent Killer" written for the layman but also widely valued by the
medical practitioner. This report may be purchased by sending $25.00 US to
him at PO Box 7685 Loveland, Colorado 80537. He has also posted a great deal
of useful information about this disease on his web page
www.Healingmatters.com He can be reached by telephone at: 1 (970) 669-9176
Surgery Tools Left in 1,500 People a Year
Wed Jan 15, 5:09 PM ET Add Health - AP to My Yahoo!
By JEFF DONN, Associated Press Writer
BOSTON - Surgical teams accidentally leave clamps, sponges and other tools
inside about 1,500 patients nationwide each year, according to the biggest
study of the problem yet. The mistakes largely result not from surgeon fatigue, but from the stress
arising from emergencies or complications discovered on the operating table,
the researchers reported. It also happens more often to fat patients, simply
because there is more room inside them to lose equipment, according to the
Both the researchers and several other experts agreed that the number of
such mistakes is small compared with the roughly 28 million operations a
year in the United States. "But no one in any role would say it's
acceptable," said Dr. Donald Berwick, president of the Boston-based
nonprofit Institute for Healthcare Improvement. The study was done by
researchers at Brigham and Women's Hospital and Harvard School of Public
Health, both in Boston. It was published in Thursday's New England Journal
of Medicine (news - web sites).
The researchers checked insurance records from about 800,000 operations in
Massachusetts for 16 years ending in 2001. They counted 61 forgotten pieces
of surgical equipment in 54 patients. From that, they calculated a national
estimate of 1,500 cases yearly. A total of $3 million was paid out in the
Massachusetts cases, mostly in settlements.
Two-thirds of the mistakes happened even though the equipment was counted
before and after the procedure, in keeping with the standard practice. Most
lost objects were sponges, but also included were metal clamps and
electrodes. In two cases, 11-inch retractors — metal strips used to hold
back tissue — were forgotten inside patients. In another operation, four
sponges were left inside someone.
The lost objects were usually lodged around the abdomen or hips but
sometimes in the chest, vagina or other cavities. They often caused tears,
obstructions or infections. One patient died of complications, but the
researchers withheld details for reasons of privacy.
Most patients needed additional surgery to remove the object, but sometimes
it came out by itself or in a doctor's office. In other cases, patients were
not even aware of the object, and it turned up in later surgery for other
problems. The study found that emergency operations are nine times more
likely to lead to such mistakes, and operating-room complications requiring
a change in procedure are four times more likely. A rise of one point in
body-mass index, a measure of weight relative to height, raises the chances
of such a
mistake by 10 percent.
The length of the operation or the hour of day does not appear to make a
difference, suggesting that fatigue does not cause such mistakes. "It tends
to be in unpredictable situations," said lead author Dr. Atul Gawande of
Brigham and Women's Hospital. Some other researchers said fatigue could
promote such mistakes in a way undetected by this study.
The Boston research team suggested that more X-ray checks be done right
after those operations where such errors are most likely. Metal instruments
and radiologically tagged sponges show up in such checks.
Eventually, wands similar to supermarket bar-code readers might be developed
to detect missing equipment, researchers said. Dr. Sidney Wolfe, health
research director of the public-interest lobby group Public Citizen, said
the real number of lost instruments may be even higher, because hospitals
are not required to report such mistakes to public agencies. He said they
should be. However, some others said such mistakes are so rare — occurring
about 50 times in 1 million operations — that figuring out how to prevent
them could be difficult.
"Something has to be done about this. It's just a very tough balance to
decide. Do we really want to add this hoop for every patient to jump
through?" said Dr. Kaveh Shojania, author of a 2001 federal study on medical
mistakes. Lori Bartholomew, research director at the Physician Insurers
Association of America, said: "I find it's going to be difficult to make
much more improvement, because some of the risk factors are things that are
hard to control." The Rockville, Md., group represents medical malpractice
ST. PAUL, Minn. (Jan. 18) - A hospital apologized for a
laboratory mistake that resulted in the amputation of a healthy woman's
breasts after she was mistakenly told she had an aggressive form of cancer.
Dr. Daniel Foley, medical director of United Hospital, told KARE-TV in the
Twin Cities that the St. Paul hospital had made changes so ''this kind of
mixup would never happen again.'' Linda McDougal, 46, said she was diagnosed
with cancer in May 2002 after her doctor had a biopsy performed when a
suspicious spot appeared on her mammogram.
McDougal said she was told the cancer was so aggressive that a double
mastectomy, chemotherapy and radiation were her only chances for survival.
In June, she had the surgery. Two days later, she was recovering when her
doctor visited. ''She had bad news,'' McDougal said. ''She didn't know how
to tell us other than to just tell us, and immediately I thought I was
dying, and she told me I didn't have cancer.''
After finding no malignancy in the amputated breast tissue, McDougal said
her doctor discovered a mistake in United's laboratory. Tissue from
McDougal's biopsy was switched with tissue from another woman. Foley said
the woman who actually had the cancer has been contacted and treated. He
would not identify the pathologist at fault, but said the doctor remains
''If you're right 99.9999 percent of the time, you don't want to be that .01
percent because the consequences are serious and we have to be right 100
percent of the time,'' Foley said. An attorney representing United's
pathologists said the group's insurance company has paid McDougal's medical
expenses and lost wages, and will continue to do so. McDougal said she is
fighting several infections and must still undergo several reconstructive
surgeries before she decides whether to sue for malpractice.
Copyright 2002 The Associated Press. The information contained in the AP
news report may not be published, broadcast, rewritten or otherwise
distributed without the prior written authority of The Associated Press. All
active hyperlinks have been inserted by AOL.
16 Quotes on Pharmaceutical Drugs
1. "The cause of most disease is in the poisonous drugs physicians
superstitiously give in order to effect a cure."
Charles E. Page, M.D.
2. "Medicines are of subordinate importance because of their very nature
they can only work symptomatically."
Hans Kusche, M.D.
3. "If all the medicine in the world were thrown into the sea, it would be
bad for the fish and good for humanity"
O.W. Holmes, (Prof. of Med. Harvard University)
4. "Drug medications consists in employing, as remedies for disease, those
things which produce disease in well persons. Its materia medica is simply a
lot of drugs or chemicals or dye-stuffs in a word poisons. All are
incompatible with vital matter; all produce disease when brought in contact
in any manner with the living; all are poisons." R.T. TraIl, M.D., in a two
and one half hour lecture to members of congress and the medical profession,
delivered at the Smithsonian Institute in Washington D.C.
5. "Every drug increases and complicates the patients condition."
Robert Henderson, M.D.
6. "Drugs never cure disease. They merely hush the voice of nature's
protest, and pull down the danger signals she erects along the pathway of
transgression. Any poison taken into the system has to be reckoned with
later on even though it palliates present symptoms. Pain may disappear, but
the patient is left in a worse condition, though unconscious of it at the
Daniel. H. Kress, M.D.
7. "The greatest part of all chronic disease is created by the suppression
of acute disease by drug poisoning." Henry Lindlahr, M.D.
8. "Every educated physician knows that most diseases are not appreciably
helped by medicine."
Richard C. Cabot, M.D. (Mass. Gen. Hospital)
9. "Medicine is only palliative, for back of disease lies the cause, and
this cause no drug can reach."
Wier Mitchel, M.D.
10. "The person who takes medicine must recover twice, once from the disease
and once from the medicine." William Osler, M.D.
11. "Medical practice has neither philosophy nor common sense to recommend
it. In sickness the body is already loaded with impurities. By taking drug -
medicines more impurities are added, thereby the case is further embarrassed
and harder to cure."
Elmer Lee, M.D., Past Vice President, Academy of Medicine.
12. "Our figures show approximately four and one half million hospital
admissions annually due to the adverse reactions to drugs. Further, the
average hospital patient has as much as thirty percent chance, depending how
long he is in, of doubling his stay due to adverse drug reactions."
Milton Silverman, M.D. (Professor of Pharmacology, University of California)
13. "Why would a patient swallow a poison because he is ill, or take that
which would make a well man sick."
L.F. Kebler, M.D.
14. "What hope is there for medical science to ever become a true science
when the entire structure of medical knowledge is built around the idea that
there is an entity called disease which can be expelled when the right drug
John H. Tilden, M.D.
15. "The necessity of teaching mankind not to take drugs and medicines, is a
duty incumbent upon all who know their uncertainty and injurious effects;
and the time is not far distant when the drug system will be abandoned."
Charles Armbruster, M. D.
16. "We are prone to thinking of drug abuse in terms of the male population
and illicit drugs such as heroin, cocaine, and marijuana. It may surprise
you to learn that a greater problem exists with millions of women dependent
on legal prescription drugs." Robert Mendelsohn, M.D
A draconian medical malpractice and medical device liability bill - H.R. 5
- has been introduced in the House. This bill devastates patients' rights
by capping non-economic damages, protecting makers of faulty medical
devices and shortening statutes of limitation, among other things. There
may be congressional votes on this legislation between the end of February
and mid-March. It is URGENT that you - and your friends, neighbors and
co-workers call your U.S. Senators and Representatives today to OPPOSE this
effort to punish patients in order to subsidize the insurance industry.
Tell your representatives that insurance companies and the drug company
lobbyist already have too much control over our healthcare system. All
members of Congress can be reached by calling: 202-224-3121.
The Administration's attacks on the jury system are nothing more than a
desperate attempt to change the subject away from the fact that the
insurance industry is receiving special treatment from its friends in the
Administration. President Bush and the Republican leadership in Congress
appear to be beholden to corporate special interests in Washington and are
trying to give the insurance industry and other big campaign contributors
(Remember Eli Lilly!!!!!!) more legal rights than injured patients and
American families have. Source: The Center for Responsive Politics,
President George W. Bush, Contributions by Sector,
Our top priority in reforming America's health-care system should be
reducing the shameful number of preventable medical errors that kill nearly
100,000 hospital patients a year - the equivalent of three fatal plane
crashes every two days. The day before President Bush attacked juries as
the cause of high malpractice insurance premiums for doctors, the New
England Journal of Medicine reported that surgical teams leave clamps,
sponges and other tools inside about 1,500 patients nationwide each year.
Source: AP, 1/15/03 President Bush is blaming the American jury system for
rising medical insurance rates but skyrocketing rates are a problem around
the world in countries that do not have a jury system like ours.
Obstetricians in France - which has strict limits on malpractice lawsuits
and no juries - recently threatened to walk off the job because of soaring
malpractice premiums. Source: The Guardian, 1/2/03
President Bush's "solutions" to the health-care crisis are being driven by
Washington special interests at the expense of states' rights. A
one-size-fits-all federal mandate that limits patients' rights in medical
malpractice cases would step on states' rights by wiping out existing state
laws and eliminating the authority of state Legislatures to control their
own court systems.
This is a message from Pedtalk - a message board for pediatricians. This
dr. won't buy thimerosal-free because of money (the date of this message is
3/5/03!!). this doctor should be in jail.
"We got the same pricing.
We've made the decision to only order the old-fashioned thimerasol laced
vaccine. Even at that, we will be LOSING $$ with some of the managed care
plans. I don't feel that we can justify the additional cost of the
thimerasol-free vaccine. I guess if some parents insist on it, I'll give
them a script and have them buy it at a pharmacy."
All the more this doc. should know better than to take the risk of using
thimerosql containing vaccines. I would suggest he attend a DAN (Defeat
Autism Now) conference. The speakers are mostly medical docs. and some have
children who are on the spectrum. The vast majority of the research done by
these docs. shows that our kids have been damaged by thimerosal.
This doc. clearly needs to look at all the research that has been done. Not
only the thimerosal issue, but vaccines themselves. However, I think some
docs., maybe most, are too concerned about losing their license to practice
if he/she becomes involved or leaning toward the anti-vax side.
This is tragic. I wonder if he vaccinated his grandchild? Dr. Usman, a DAN
doc., said she vaccinated her own child w/o the knowledge of thimerosal and
that child is autistic (vaccine damaged). Interesting enough, she said
publicly that her last child is completely vaccine free! I guess some
docs get it and some don't. I find it hard to believe that he could be so
closed minded. And you would think as a doc. he would understand more
concerning the vaccine issue. It sounds like it is all about $ for this
A Free Ride for Bad Doctors (HRG Publication #1655)
This Op-Ed by Sidney Wolfe, M.D. appeared in the March 4, 2003 edition of
the New York Times
A Free Ride for Bad Doctors
The death of Jésica Santillán, the 17-year-old given a heart and lung
transplant last month from an incompatible donor, has become the latest
argument in Congress against President Bush's plan to limit malpractice
damage awards. With doctors in several states staging work stoppages to
protest the soaring costs of premiums, the plan to put caps on
pain-and-suffering payouts had been picking up steam.
Yet in all the discussion of tragic cases and dollar amounts, a major cause
of the malpractice problem is ignored: the failure of state medical boards
to discipline doctors.
The fact is, only a small percentage of doctors account for most of the
money paid out in malpractice cases. From 1990 to 2002, just 5 percent of
doctors were involved in 54 percent of the payouts — including jury awards
and out-of-court settlements — according to the National Practitioner Data
Bank of the Department of Health and Human Services. (The data bank allows
hospitals and medical boards to see the records of individual doctors but,
thanks to pressure from the American Medical Association, Congress forbids
it to release information to doctors or the public.)
Of the 35,000 doctors with two or more payouts during that period, only 8
percent were disciplined by state medical boards. Among the 2,774 doctors
who had made payments in five or more cases, only 463 — one out of six — had
Is it any coincidence that the states least likely to discipline doctors are
among those with insurance crises? Pennsylvania — where the governor had to
intervene to keep doctors from going out on strike over malpractice
insurance costs — has disciplined only 5 percent of the 512 doctors who had
made payments in malpractice suits five or more times, the lowest percentage
of any state. (Arizona, for example, has disciplined nearly half of the
doctors in this category.)
And while Pennsylvania has 5.3 percent of the doctors in the United States,
they make up 18.5 percent of American doctors with five or more malpractice
payments. One doctor there paid 24 claims between 1993 and 2001 totaling
more than $8 million (one was for operating on the wrong part of the body;
another was for leaving a "foreign body" in the patient) yet was never
disciplined by Pennsylvania authorities.
The state with the next highest overrepresentation of doctors with five or
more payouts is West Virginia, where doctors went on strike last month. It
has 0.57 percent of the country's physicians, but they make up 1.69 percent
of American doctors who have had made malpractice payments five or more
times. Only one-quarter of the state's doctors with five or more payouts has
been disciplined by the medical board.
In New York, another state with a pending malpractice crisis, the number of
doctors who have had five or more malpractice payments is two and one-half
times higher than would be expected from the number of doctors licensed. Yet
only 15 percent of these 698 doctors have been disciplined by the state
Amid the uproar about malpractice premium increases, there is a deadly
silence from physicians' groups on the crisis of inadequate doctor
discipline. The problem is not the compensation paid to injured patients,
but an epidemic of medical errors. If medical boards, which are state
agencies, areunwilling to seriously discipline doctors who repeatedly pay
for malpractice — including revoking medical licenses from the worst
offenders — then legislatures must step in and change the way the boards
Congress should also rethink the secrecy surrounding the practitioner data
bank. While a few states release some data to the public, most Americans
have no way of finding out their doctors' backgrounds. What patient would
not like to discover the malpractice history of a potential doctor,
especially if he is among the 2,774 in the United States who have had five
or more payouts?
Parents of Dead Child Sue Over Transplant
Parents of Dead Child Sue Doctors, Hospitals Over Blood-Type Mistake in
The Associated Press
DALLAS March 12 —
The parents of a 17-month-old girl who died last summer after receiving a
transplanted liver that didn't match her blood type are suing two Dallas
hospitals and three surgeons who were involved. The lawsuit alleges that
doctors mistakenly gave Jeanella Aranda a liver transplant from her father
instead of from her mother. The mother and child had type O blood; the
father is type A.
The case recalls the death last month of Jesica Santillan, the teenager who
underwent two heart-lung transplants in North Carolina. As with Jeanella,
Jesica's first transplanted organs had been the wrong blood type and her
body rejected them. Her parents have not said if they will sue.
According to the lawsuit filed Monday in Texas, a surgeon at Children's
Medical Center severed the blood veins and arteries around Jeanella's liver,
causing uncontrollable bleeding. Hospital officials told the girl's parents
she needed a transplant and recommended they be tested as possible donors.
A laboratory that performed the blood typing for Jeanella and her parents
mixed up the blood types of the parents and incorrectly identified the
father as a suitable donor of a partial liver. Partial liver donations are
becoming more common because livers regenerate quickly in donor and
recipient alike. The father went to Baylor University Medical Center, where
surgeons removed part of his liver and sent it to Children's Medical Center.
It was transplanted into Jeanella in July.
After the transplant, the girl developed a blood disorder, fever, kidney
problems, lung hemorrhages and jaundice. But the blood type mismatch was not
detected until 19 days after the surgery, when the mother noticed that
Jeanelle's transfusions were type O, and asked whether the transplant had
been a mismatch.
Doctors realized she was correct. The girl died the next day. The parents,
Cesar and Alicia Aranda, are suing both hospitals and the doctors who
operated on Jeanella and Cesar Aranda, claiming both hospitals should have
double-checked the blood types.
The physicians named in the lawsuit are Dr. Robert Goldstein, Dr. Philip
Guzzetta and Dr. Jay Roden, who were involved in the operations. In
statements issued Tuesday, both hospitals said they understood the father's
blood type to be a match, The Dallas Morning News reported Wednesday.
"An exhaustive review of the care Jeanella received at our hospital has been
conducted, and Children's believes it acted appropriately, based on the
information provided to us by an external laboratory," the hospital's
statement read in part
Patient Dies in VA Medical Study
Patient Dies As Result of Medical Error in Veterans Affairs Medical
Study, Prompting Review
The Associated Press
WASHINGTON March 12 —
At least one patient died recently as a result of a medical error in a study
at a Veterans Affairs hospital, prompting a review of the agency's entire
human research effort, according to a memo released Wednesday.
The memo, signed by two deputy undersecretaries for health and dated March
6, called for an intensive 90-day review at all VA medical centers of
procedures used to monitor human research. Current projects will continue
and patients will still be enrolled in new ones, the memo said.
The memo referred to the death "of one or more patients at one site," but
did not describe the human experiments or offer any details. A House VA
committee staffer said, however, the memo refers to a cancer patient who
died last year during a drug trial conducted at a VA medical center in
Albany, N.Y. The staffer said the death was being investigated by federal
authorities, including the FBI. He said the investigation has shown that at
least one researcher in the study had falsified credentials and did not hold
a valid medical license.VA spokeswoman Karen Fedele said the agency would
not comment further, citing an investigation by the VA's inspector general.
Dr. Jonathan B. Perlin and Laura J. Miller, the deputy undersecretaries who
signed the memo, were not available for comment and a receptionist referred
all questions to Louise Van Diepen, an associate in their office. She
refused to discuss the memo. The Perlin-Miller memo said recent incidents in
VA center human research studies "have had the potential to put research
subjects at risk."
Among the incidents cited:
Falsification of individual patient data "contributed" to the death of at
least one patient. Overdosing of a patient in a drug study project at
An experimental procedure was conducted without the prior approval of the
Institutional Review Board or the Research and Development Committee panels
that have the formal responsibility of monitoring human research. A drug
study was conducted without a researcher who had clinical privileges
permitting the prescribing of the study medication. Failure of a review
board "to meet even the minimal standards required."
Perlin and Miller ordered the 90-day review "to ensure we are doing all that
is possible to ensure the protection of human subjects and the ethical
conduct of research." The memo directed that directors and other officials
at VA centers are to review the operations of review boards and R&D
committees to assure they are "functioning at least at the minimum level
The memo required that all researchers and the members of the oversight
boards complete training courses on the protection of human research
subjects. It also called for new procedures to assure that all researchers
have the proper credentials and licenses. Finally, the memo warned that
principle researchers at the VA centers "will be held responsible for
ethical breaches in the conduct of their research."
Half of all hospital drug injections are wrong
00:01 28 March 03 NewScientist.com news service
Half of all drug injections given intravenously in hospitals are done
wrongly, a new study reveals, with third of these being potentially
British researchers uncovered the disturbing level of errors when they
examined drugs given intravenously by nurses in two hospitals in the UK.
They believe the rate of mistakes they found is likely to be representative
of practice across Europe and the US.
Nick Barber and Katja Taxis, at the School of Pharmacy, London, tracked the
preparation and administration of over 400 intravenous (IV) doses given to
patients on 10 different wards in the hospitals. "We were surprised about
how commonly errors occurred," say Barber. "But not all of these were
However, the error rate they calculated from their data predicts one serious
error every day in every hospital in the UK, which is a concern, he says.
The most common mistakes were injecting doses of concentrated drugs too
rapidly and preparing drugs incorrectly, by either using the wrong dose or
dissolving them in the wrong solution. All could be fatal in certain
For some drugs, the speed at which it enters the body is crucial, Barber
explains. If they are injected too fast, they can induce anaphylaxis - a
life-threatening allergic reaction.
"This is because there is a load of potent foreign chemical shooting around
your body - if it hits the brain or heart it can have a marked effect," he
said. But injecting a drug slowly, for example, over three minutes can be
physically difficult for health care staff.
One of the three "potentially severe" errors Barber and Taxis in their study
was of this type - with the antibiotic vancomycin being given too quickly.
However, a pharmacist observer for the study intervened before any harm was
Nick Barber, School of Pharmacy, London National Patient Safety Agency, UK
British Medical Journal The second severe error occurred when a patient was
nearly injected with an IV preparation containing five times the correct
dose of heparin - which stops the blood clotting. "Wrong dose errors are the
ones most likely to cause harm," notes Barber. The third potentially lethal
error was when an intensive care team infusing a patient with adrenalin ran
out of the drug and had not prepared a second infusion in time. Barber says
the key to tackling such errors was to improve nurse training. He says there
would also be a role for companies to develop a simple pump to help nurses
administer drugs slowly.
Journal reference: British Medical Journal (vol 326, p 684)
Schools shift rules on pelvic procedure
Exams often done without consent
By David B. Caruso
Published March 12, 2003
PHILADELPHIA -- Some of the nation's leading medical schools have abandoned
a little-known, decades-old practice of letting students perform pelvic
exams on women without their consent while they are under anesthesia.
The institutions that have recently implemented policies of asking for
permission routinely brought in students--sometimes as many as three or
four--to conduct pelvic exams on unconscious women just before their
gynecological surgeries, often without their consent. Changes in that
practice have taken place over the past five years after complaints from
students who felt the exams without consent were unethical. "My problem was
that if they found out about it, they might be really upset, and it was
really only being done for my benefit," said Dr. Ari Silver-Isenstadt, who
refused to examine anesthetized women as a student at
the University of Pennsylvania.
Students also raised objections in the mid-1990s at Harvard Medical
School.Dr. Daniel Federman, senior dean for clinical teaching at Harvard,
said the complaints led to a new policy under which surgical patients had to
give consent for a pelvic exam for training purposes. In addition, the
students had to be part of the medical team. "Very few patients decline,"
Federman said. "And when they do, we honor it." At the University of
California-San Francisco, complaints by medical students in the late 1990s
led to a line being added to patient consent forms, specifically noting that
women having gynecological surgery may be given a pelvic exam while they
are under anesthesia.
Typically, the surgeon performing the operation conducts an exam to confirm
the problem to be corrected by surgery. Dr. Patricia Robertson, director of
UCSF's obstetrics and gynecology clerkship, said students also have been
directed to meet the patient before each operation and explain how they will
be involved in their care. "The students, I think, were most upset because
they felt there were students lining up in the operating room doing pelvic
exams who really had nothing to do with the patient," she said.
Most medical students today learn basics of the pelvic exam by practicing on
paid volunteers. Anesthetized women are the perfect subjects, doctors said,
because they are unable to feel the sometimes painful mistakes of novice
examiners. Consent is still far from a universal practice. At the Washington
University School of Medicine in St. Louis, for instance, patients are told
that students will be part of their care team, but aren't specifically told
the treatment could include a pelvic exam for educational purposes.
"I don't think any of us even think about it," said Dr. Jessica Bienstock,
residency program director at Johns Hopkins University. "It's just so
standard as to how you train medical students." Many students, however,
appear to disagree: 70 percent surveyed at Philadelphia-area hospitals in
1995 before they completed an obstetrics and gynecology clerkship said it
was important to ask women for consent, according to a study published last
month in the American Journal of Obstetrics and Gynecology.
Dr. Michael Gregory, a Boston public health physician who objected to the
exams when he was a third-year student at Tufts University School of
Medicine, said that while studies show most women will give their consent,
doctors are afraid to ask. "It's this paternalistic, patronizing view that
the doctors know best. ... We underestimate people's incredible charity, and
their willingness to let us train," he said. "But I think that at a gut
level, doctors understand that if they actually told patients that this was
happening without their consent, people would be outraged."
Patient safety is a top priority in the Nation today. The Institute of
Medicine (IOM) report entitled "To Err is Human", (in ref. 9) estimated that
between 44,000 and 98,000 people die each year in hospitals from medical
errors. The majority of these errors are a result of systemic problems
rather than poor performance by individual providers. Although, the United
States provides some of the best health care in the world, the number of
patients that are being harmed as a result of the process of health care is
unacceptably high. In response to the IOM report, the Quality Interagency
Coordination Task Force (QuIC), which is composed of Federal members
representing the Departments of Health and Human Services (DHHS), Labor
(DoL), Defense (DoD), Veterans Affairs (VA), and Commerce; Office of
Management and Budget (OMB); Office of Personnel Management (OPM); U.S.
Coast Guard, Federal Bureau of Prisons (BoP); National Highway
Transportation and Safety Administration; and the Federal Trade Commission
(FTC), issued a report in February 2000 "Doing What Counts for Patient
Safety, Federal Action to Reduce Medical Errors and Their Impact". (See ref.
The Soft Science of Dietary Fat by Gary Taubes Science magazine Mainstream
nutritional science has demonized dietary fat, yet 50 years and hundreds of
millions of dollars of research have failed to prove that eating a low-fat
diet will help you live longer When the U.S. Surgeon General's Office set
off in 1988 to write the definitive report on the dangers of dietary fat,
the scientific task appeared straightforward. Four years earlier, the
National Institutes of Health (NIH) had begun advising every American old
enough to walk to restrict fat intake, and the president of the American
Heart Association (AHA) had told Time magazine that if everyone went along,
"we will have [atherosclerosis] conquered" by the year 2000. The Surgeon
General's Office itself had just published its 700-page landmark "Report on
Nutrition and Health," declaring fat the single most unwholesome component
of the American diet.
All of this was apparently based on sound science. So the task before the
project officer was merely to gather that science together in one volume,
have it reviewed by a committee of experts, which had been promptly
established, and publish it. The project did not go smoothly, however. Four
project officers came and went over the next decade. "It consumed project
officers," says Marion Nestle, who helped launch the project and now runs
the nutrition and food studies department at New York University (NYU).
Members of the oversight committee saw drafts of an early chapter or two,
criticized them vigorously, and then saw little else.
Finally, in June 1999, 11 years after the project began, the Surgeon
General's Office circulated a letter, authored by the last of the project
officers, explaining that the report would be killed. There was no other
public announcement and no press release. The letter explained that the
relevant administrators "did not anticipate fully the magnitude of the
additional external expertise and staff resources that would be needed."
In other words, says Nestle, the subject matter "was too complicated." Bill
Harlan, a member of the oversight committee and associate director of the
Office of Disease Prevention at NIH, says "the report was initiated with a
preconceived opinion of the conclusions," but the science behind those
opinions was not holding up.
"Clearly the thoughts of yesterday were not going to serve us very well."
During the past 30 years, the concept of eating healthy in America has
become synonymous with avoiding dietary fat. The creation and marketing of
reduced-fat food products has become big business; over 15,000 have appeared
on supermarket shelves. Indeed, an entire research industry has arisen to
create palatable nonfat fat substitutes, and the food industry now spends
billions of dollars yearly selling the less-fat-is-good-health message. The
government weighs in as well, with the U.S. Department of Agriculture's
(USDA's) booklet on dietary guidelines, published every 5 years, and its
ubiquitous Food Guide Pyramid, which recommends that fats and oils be eaten
"sparingly." The low-fat gospel spreads farther by a kind of societal
osmosis, continuously reinforced by physicians, nutritionists, journalists,
health organizations, and consumer advocacy groups such as the Center for
Science in the Public Interest, which refers to fat as this "greasy killer."
"In America, we no longer fear
God or the communists, but we fear fat," says David Kritchevsky of the
Wistar Institute in Philadelphia, who in 1958 wrote the first textbook on
As the Surgeon General's Office discovered, however, the science of dietary
fat is not nearly as simple as it once appeared. The proposition, now 50
years old, that dietary fat is a bane to health is based chiefly on the fact
that fat, specifically the hard, saturated fat found primarily in meat and
dairy products, elevates blood cholesterol levels. This in turn raises the
likelihood that cholesterol will clog arteries, a condition known as
atherosclerosis, which then increases risk of coronary artery disease, heart
attack, and untimely death. By the
1970s, each individual step of this chain from fat to cholesterol to heart
disease had been demonstrated beyond reasonable doubt, but the veracity of
the chain as a whole has never been proven. In other words, despite decades
of research, it is still a debatable proposition whether the consumption of
saturated fats above recommended levels (step one in the chain) by anyone
who's not already at high risk of heart disease will increase the likelihood
of untimely death (outcome three). Nor have hundreds of millions of dollars
in trials managed to generate compelling evidence that healthy individuals
can extend their lives by more than a few weeks, if that, by eating less fat
(see sidebar on p. 2538). To put it simply, the data remain ambiguous as to
whether low-fat diets will benefit healthy Americans. Worse, the ubiquitous
admonishments to reduce total fat intake have encouraged a shift to
high-carbohydrate diets, which may be no better--and may even be worse--than
Since the early 1970s, for instance, Americans' average fat intake has
dropped from over 40% of total calories to 34%; average serum cholesterol
levels have dropped as well. But no compelling evidence suggests that these
decreases have improved health. Although heart disease death rates have
dropped--and public health officials insist low-fat diets are partly
responsible--the incidence of heart disease does not seem to be declining,
as would be expected if lower fat diets made a difference. This was the
conclusion, for instance, of a 10-year study of heart disease mortality
published in The New England Journal of Medicine in 1998, which suggested
that death rates are declining largely because doctors are treating the
disease more successfully.
AHA statistics agree: Between 1979 and 1996, the number of medical
procedures for heart disease increased from 1.2 million to 5.4 million a
year. "I don't consider that this disease category has disappeared or
anything close to it," says one AHA statistician.
Meanwhile, obesity in America, which remained constant from the early 1960s
through 1980, has surged upward since then--from 14% of the population to
over 22%. Diabetes has increased apace. Both obesity and diabetes increase
heart disease risk, which could explain why heart disease incidence is not
decreasing. That this obesity epidemic occurred just as the government began
bombarding Americans with the low-fat message suggests the possibility,
however distant, that low-fat diets might have unintended
consequences--among them, weight gain. "Most of us would have predicted that
if we can get the population to change its fat intake, with its dense
calories, we would see a reduction in weight," admits Harlan. "Instead, we
see the exact opposite."
In the face of this uncertainty, skeptics and apostates have come along
repeatedly, only to see their work almost religiously ignored as the
mainstream medical community sought consensus on the evils of dietary fat.
For 20 years, for instance, the Harvard School of Public Health has run the
Nurses' Health Study and its two sequelae--the Health Professionals
Follow-Up Study and the Nurses' Health Study II--accumulating over a decade
of data on the diet and health of almost 300,000 Americans. The results
suggest that total fat consumed has no relation to heart disease risk; that
monounsaturated fats like olive oil lower risk; and that saturated fats are
little worse, if at all, than the pasta and other carbohydrates that the
Food Guide Pyramid suggests be eaten copiously. (The studies also suggest
that trans fatty acids are unhealthful. These are the fats in margarine, for
instance, and are what many Americans started eating when they were told
that the saturated fats in butter might kill them.) Harvard epidemiologist
Walter Willett, spokesperson for the Nurses' Health Study, points out that
NIH has spent over $100 million on the three studies and yet not one
government agency has changed its
primary guidelines to fit these particular data. "Scandalous," says Willett.
"They say, 'You really need a high level of proof to change the
recommendations,' which is ironic, because they never had a high level of
proof to set them."
Indeed, the history of the national conviction that dietary fat is deadly,
and its evolution from hypothesis to dogma, is one in which politicians,
bureaucrats, the media, and the public have played as large a role as the
scientists and the science. It's a story of what can happen when the demands
of public health policy--and the demands of the public for simple
advice--run up against the confusing ambiguity of real science.
Fear of fat During the first half of the 20th century, nutritionists were
more concerned about malnutrition than about the sins of dietary excess.
After World War II, however, a coronary heart disease epidemic seemed to
sweep the country (see sidebar on p. 2540). "Middle-aged men, seemingly
healthy, were dropping dead," wrote biochemist Ancel Keys of the University
of Minnesota, Twin Cities, who was among the first to suggest that dietary
fats might be the cause. By 1952, Keys was arguing that Americans should
reduce their fat intake to less than 30% of total calories, although he
simultaneously recognized that "direct evidence on the effect of the diet on
human arteriosclerosis is very little and likely to remain so for some
time." In the famous and very controversial Seven Countries Study, for
instance, Keys and his colleagues reported that the amount of fat consumed
seemed to be the salient difference between populations such as those in
Japan and Crete that had little heart
disease and those, as in Finland, that were plagued by it. In 1961, the
Framingham Heart Study linked cholesterol levels to heart disease, Keys made
the cover of Time magazine, and the AHA, under his influence, began
advocating low-fat diets as a palliative for men with high cholesterol
levels. Keys had also become one of the first Americans to consciously adopt
a heart-healthy diet: He and his wife, Time reported, "do not eat 'carving
meat'--steaks, chops, roasts--more than three times a week."
Nonetheless, by 1969 the state of the science could still be summarized by a
single sentence from a report of the Diet-Heart Review Panel of the National
Heart Institute (now the National Heart, Lung, and Blood Institute, or
NHLBI): "It is not known whether dietary manipulation has any effect
whatsoever on coronary heart disease." The chair of the panel was E. H.
"Pete" Ahrens, whose laboratory at Rockefeller University in New York City
did much of the seminal research on fat and cholesterol metabolism.
Whereas proponents of low-fat diets were concerned primarily about the
effects of dietary fat on cholesterol levels and heart disease, Ahrens and
his panel--10 experts in clinical medicine, epidemiology, biostatistics,
human nutrition, and metabolism--were equally concerned that eating less fat
could have profound effects throughout the body, many of which could be
harmful. The brain, for instance, is 70% fat, which chiefly serves to
insulate neurons. Fat is also the primary component of cell membranes.
Changing the proportion of saturated to unsaturated fats in the diet changes
the fat composition in these membranes. This could conceivably change the
membrane permeability, which controls the transport of everything from
glucose, signaling proteins, and hormones to bacteria, viruses, and
tumor-causing agents into and out of the cell. The relative saturation of
fats in the diet could also influence cellular aging as well as the clotting
ability of blood cells.
Whether the potential benefits of low-fat diets would exceed the potential
risks could be settled by testing whether low-fat diets actually prolong
life, but such a test would have to be enormous. The effect of diet on
cholesterol levels is subtle for most individuals--especially those living
in the real world rather than the metabolic wards of nutrition
researchers--and the effect of cholesterol levels on heart disease is also
subtle. As a result, tens of thousands of individuals would have to switch
to low-fat diets and their subsequent health compared to that of equal
numbers who continued eating fat to alleged excess. And all these people
would have to be followed for years until enough deaths accumulated to
provide statistically significant results.
Ahrens and his colleagues were pessimistic about whether such a massive and
expensive trial could ever be done. In 1971, an NIH task force estimated
such a trial would cost $1 billion, considerably more than NIH was willing
to spend. Instead, NIH administrators opted for a handful of smaller
studies, two of which alone would cost $255 million. Perhaps more important,
these studies would take a decade. Neither the public, the press, nor the
U.S. Congress was willing to wait that long.
Science by committee Like the flourishing American affinity for alternative
medicine, an antifat movement evolved independently of science in the 1960s.
It was fed by distrust of the establishment--in this case, both the medical
establishment and the food industry--and by counterculture attacks on
excessive consumption, whether manifested in gas-guzzling cars or the
classic American cuisine of bacon and eggs and marbled steaks. And while the
data on fat and health remained ambiguous and the scientific community
polarized, the deadlock was broken not by any new science, but by
politicians. It was Senator George McGovern's bipartisan, nonlegislative
Select Committee on Nutrition and Human Needs--and, to be precise, a handful
of McGovern's staff members--that almost single-handedly changed nutritional
policy in this country and initiated the process of turning the dietary fat
hypothesis into dogma.
McGovern's committee was founded in 1968 with a mandate to eradicate
malnutrition in America, and it instituted a series of landmark federal food
assistance programs. As the malnutrition work began to peter out in the
mid-1970s, however, the committee didn't disband. Rather, its general
counsel, Marshall Matz, and staff director, Alan Stone, both young lawyers,
decided that the committee would address "overnutrition," the dietary
excesses of Americans. It was a "casual endeavor," says Matz. "We really
were totally naïve, a bunch of kids, who just thought, 'Hell, we should say
something on this subject before we go out of business.' "
McGovern and his fellow senators--all middle-aged men worried about their
girth and their health--signed on; McGovern and his wife had both gone
through diet-guru Nathan Pritikin's very low fat diet and exercise program.
McGovern quit the program early, but Pritikin remained a major influence on
McGovern's committee listened to 2 days of testimony on diet and disease in
July 1976. Then resident wordsmith Nick Mottern, a former labor reporter for
The Providence Journal, was assigned the task of researching and writing the
first "Dietary Goals for the United States." Mottern, who had no scientific
background and no experience writing about science, nutrition, or health,
believed his Dietary Goals would launch a "revolution in diet and
agriculture in this country." He avoided the scientific and medical
controversy by relying almost exclusively on Harvard School of Public Health
nutritionist Mark Hegsted for input on dietary fat. Hegsted had studied fat
and cholesterol metabolism in the early 1960s, and he believed
unconditionally in the benefits of restricting fat intake, although he says
he was aware that his was an extreme opinion. With Hegsted as his muse,
Mottern saw dietary fat as the nutritional equivalent of cigarettes, and the
food industry as akin to the tobacco
industry in its willingness to suppress scientific truth in the interests of
profits. To Mottern, those scientists who spoke out against fat were those
willing to take on the industry. "It took a certain amount of guts," he
says, "to speak about this because of the financial interests involved."
Mottern's report suggested that Americans cut their total fat intake to 30%
of the calories they consume and saturated fat intake to 10%, in accord with
AHA recommendations for men at high risk of heart disease. The report
acknowledged the existence of controversy but insisted Americans had nothing
to lose by following its advice. "The question to be asked is not why should
we change our diet but why not?" wrote Hegsted in the introduction. "There
are [no risks] that can be identified and important benefits can be
expected." This was an optimistic but still debatable position, and when
Dietary Goals was released in January 1977, "all hell broke loose," recalls
Hegsted. "Practically nobody was in favor of the McGovern recommendations.
Damn few people."
McGovern responded with three follow-up hearings, which aptly foreshadowed
the next 7 years of controversy. Among those testifying, for instance, was
NHLBI director Robert Levy, who explained that no one knew if eating less
fat or lowering blood cholesterol levels would prevent heart attacks, which
was why NHLBI was spending $300 million to study the question. Levy's
position was awkward, he recalls, because "the good senators came out with
the guidelines and then called us in to get advice." He was joined by
prominent scientists, including Ahrens, who testified that advising
Americans to eat less fat on the strength of such marginal evidence was
equivalent to conducting a nutritional experiment with the American public
as subjects. Even the American Medical Association protested, suggesting
that the diet proposed by the guidelines raised the "potential for harmful
effects." But as these scientists testified, so did representatives from the
dairy, egg, and cattle industries, who
also vigorously opposed the guidelines for obvious reasons.
This juxtaposition served to taint the scientific criticisms: Any scientists
arguing against the committee's guidelines appeared to be either hopelessly
behind the paradigm, which was Hegsted's view, or industry apologists, which
was Mottern's, if not both.
Although the committee published a revised edition of the Dietary Goals
later in the year, the thrust of the recommendations remained unchanged. It
did give in to industry pressure by softening the suggestion that Americans
eat less meat. Mottern says he considered even that a "disservice to the
public," refused to do the revisions, and quit the committee. (Mottern
became a vegetarian while writing the Dietary Goals and now runs a food
co-op in Peekskill, New York.)
The guidelines might have then died a quiet death when McGovern's committee
came to an end in late 1977 if two federal agencies had not felt it
imperative to respond. Although they took contradictory points of view, one
message--with media assistance--won out.
The first was the USDA, where consumer-activist Carol Tucker Foreman had
recently been appointed an assistant secretary. Foreman believed it was
incumbent on USDA to turn McGovern's recommendations into official policy,
and, like Mottern, she was not deterred by the existence of scientific
controversy. "Tell us what you know and tell us it's not the final answer,"
she would tell scientists. "I have to eat and feed my children three times a
day, and I want you to tell me what your best sense of the data is right
Of course, given the controversy, the "best sense of the data" would depend
on which scientists were asked.
The Food and Nutrition Board of the National Academy of Sciences (NAS),
which decides the Recommended Dietary Allowances, would have been a natural
choice, but NAS president Philip Handler, an expert on metabolism, had told
Foreman that Mottern's Dietary Goals were "nonsense." Foreman then turned to
McGovern's staffers for advice and they recommended she hire Hegsted, which
she did. Hegsted, in turn, relied on a state-of-the-science report published
by an expert but very divergent committee of the American Society for
Clinical Nutrition. "They were nowhere near unanimous on anything," says
Hegsted, "but the majority supported something like the McGovern committee
The resulting document became the first edition of "Using the Dietary
Guidelines for Americans." Although it acknowledged the existence of
controversy and suggested that a single dietary recommendation might not
suit an entire diverse population, the advice to avoid fat and saturated fat
was, indeed, virtually identical to McGovern's Dietary Goals.
Three months later, the NAS Food and Nutrition Board released its own
guidelines: "Toward Healthful Diets."
The board, consisting of a dozen nutrition experts, concluded that the only
reliable advice for healthy Americans was to watch their weight; everything
else, dietary fat included, would take care of itself. The advice was not
taken kindly, however, at least not by the media. The first reports--"rather
incredulously," said Handler at the time--criticized the NAS advice for
conflicting with the USDA's and McGovern's and thus somehow being
irresponsible. Follow-up reports suggested that the board members, in the
words of Jane Brody, who covered the story for The New York Times, were "all
in the pocket of the industries being hurt."
To be precise, the board chair and one of its members consulted for food
industries, and funding for the board itself came from industry donations.
These industry connections were leaked to the press from the USDA.
Hegsted now defends the NAS board, although he didn't at the time, and calls
this kind of conflict of interest "a hell of an issue." "Everybody used to
complain that industry didn't do anything on nutrition," he told Science,
"yet anybody who got involved was blackballed because their positions were
presumably influenced by the industry." (In 1981, Hegsted returned to
Harvard, where his research was funded by Frito-Lay.) The press had mixed
feelings, claiming that the connections "soiled" the academy's reputation
"for tendering careful scientific advice" (The Washington Post),
demonstrated that the board's "objectivity and aptitude are in doubt" (The
New York Times), or represented in the board's guidelines a "blow against
the food faddists who hold the public in thrall" (Science). In any case, the
NAS board had been publicly discredited. Hegsted's Dietary Guidelines for
Americans became the official U.S. policy on dietary fat: Eat less fat. Live
Once politicians, the press, and the public had decided dietary fat policy,
the science was left to catch up. In the early 1970s, when NIH opted to
forgo a $1 billion trial that might be definitive and instead fund a
half-dozen studies at one-third the cost, everyone hoped these smaller
trials would be sufficiently persuasive to conclude that low-fat diets
prolong lives. The results were published between 1980 and 1984. Four of
these trials --comparing heart disease rates and diet within Honolulu,
Puerto Rico, Chicago, and Framingham--showed no evidence that men who ate
less fat lived longer or had fewer heart attacks. A fifth trial, the
Multiple Risk Factor Intervention Trial (MRFIT), cost $115 million and tried
to amplify the subtle influences of diet on health by persuading subjects to
avoid fat while simultaneously quitting smoking and taking medication for
high blood pressure. That trial suggested, if anything, that eating less fat
might shorten life. In each study, however,
the investigators concluded that methodological flaws had led to the
negative results. They did not, at least publicly, consider their results
reason to lessen their belief in the evils of fat.
The sixth study was the $140 million Lipid Research Clinics (LRC) Coronary
Primary Prevention Trial, led by NHLBI administrator Basil Rifkind and
biochemist Daniel Steinberg of the University of California, San Diego.
The LRC trial was a drug trial, not a diet trial, but the NHLBI heralded its
outcome as the end of the dietary fat debate. In January 1984, LRC
investigators reported that a medication called cholestyramine reduced
cholesterol levels in men with abnormally high cholesterol levels and
modestly reduced heart disease rates in the process. (The probability of
suffering a heart attack during the seven-plus years of the study was
reduced from 8.6% in the placebo group to 7.0%; the probability of dying
from a heart attack dropped from 2.0% to
1.6%.) The investigators then concluded, without benefit of dietary data,
that cholestyramine's benefits could be extended to diet as well. And
although the trial tested only middle-aged men with cholesterol levels
higher than those of 95% of the population, they concluded that those
benefits "could and should be extended to other age groups and women and ...
other more modest elevations of cholesterol levels."
Why go so far? Rifkind says their logic was simple: For 20 years, he and his
colleagues had argued that lowering cholesterol levels prevented heart
attacks. They had spent enormous sums trying to prove it. They felt they
could never actually demonstrate that low-fat diets prolonged lives--that
would be too expensive, and MRFIT had failed--but now they had established a
fundamental link in the causal chain, from lower cholesterol levels to
cardiovascular health. With that, they could take the leap of faith from
cholesterol-lowering drugs and health to cholesterol-lowering diet and
health. And after all their effort, they were eager--not to mention urged by
Congress--to render helpful advice. "There comes a point when, if you don't
make a decision, the consequences can be great as well," says Rifkind. "If
you just allow Americans to keep on consuming 40% of calories from fat,
there's an outcome to that as well."
With the LRC results in press, the NHLBI launched what Levy called "a
massive public health campaign." The media obligingly went along. Time, for
instance, reported the LRC findings under the headline "Sorry, It's True.
Cholesterol really is a killer." The article about a drug trial began: "No
whole milk. No butter. No fatty meats ..." Time followed up 3 months later
with a cover story: "And Cholesterol and Now the Bad News. ..."
The cover photo was a frowning face: a breakfast plate with two fried eggs
as the eyes and a bacon strip for the mouth. Rifkind was quoted saying that
their results "strongly indicate that the more you lower cholesterol and fat
in your diet, the more you reduce your risk of heart disease," a statement
that still lacked direct scientific support.
The following December, NIH effectively ended the debate with a "Consensus
Conference." The idea of such a conference is that an expert panel, ideally
unbiased, listens to 2 days of testimony and arrives at a conclusion with
which everyone agrees. In this case, Rifkind chaired the planning committee,
which chose his LRC co-investigator Steinberg to lead the expert panel. The
20 speakers did include a handful of skeptics
--including Ahrens, for instance, and cardiologist Michael Oliver of
Imperial College in London--who argued that it was unscientific to equate
the effects of a drug with the effects of a diet. Steinberg's panel members,
however, as Oliver later complained in The Lancet, "were selected to include
only experts who would, predictably, say that all levels of blood
cholesterol in the United States are too high and should be lowered.
And, of course, this is exactly what was said." Indeed, the conference
report, written by Steinberg and his panel, revealed no evidence of discord.
There was "no doubt," it concluded, that low-fat diets "will afford
significant protection against coronary heart disease" to every American
over 2 years old. The Consensus Conference officially gave the appearance of
unanimity where none existed. After all, if there had been a true consensus,
as Steinberg himself told Science, "you wouldn't have had to have a
The test of time To the outside observer, the challenge in making sense of
any such long-running scientific controversy is to establish whether the
skeptics are simply on the wrong side of the new paradigm, or whether their
skepticism is well founded. In other words, is the science at issue based on
sound scientific thinking and unambiguous data, or is it what Sir Francis
Bacon, for instance, would have called "wishful science," based on fancies,
opinions, and the exclusion of contrary evidence? Bacon offered one viable
suggestion for differentiating the two: the test of time. Good science is
rooted in reality, so it grows and develops and the evidence gets
increasingly more compelling, whereas wishful science flourishes most under
its first authors before "going downhill."
Such is the case, for instance, with the proposition that dietary fat causes
cancer, which was an integral part of dietary fat anxiety in the late 1970s.
By 1982, the evidence supporting this idea was thought to be so undeniable
that a landmark NAS report on nutrition and cancer equated those researchers
who remained skeptical with "certain interested parties [who] formerly
argued that the association between lung cancer and smoking was not
causational." Fifteen years and hundreds of millions of research dollars
later, a similarly massive expert report by the World Cancer Research Fund
and the American Institute for Cancer Research could find neither
"convincing" nor even "probable" reason to believe that dietary fat caused
The hypothesis that low-fat diets are the requisite route to weight loss has
taken a similar downward path.
This was the ultimate fallback position in all low-fat recommendations: Fat
has nine calories per gram compared to four calories for carbohydrates and
protein, and so cutting fat from the diet surely would cut pounds. "This is
held almost to be a religious truth," says Harvard's Willett. Considerable
data, however, now suggest otherwise. The results of well-controlled
clinical trials are consistent: People on low-fat diets initially lose a
couple of kilograms, as they would on any diet, and then the weight tends to
return. After 1 to 2 years, little has been achieved. Consider, for
instance, the 50,000 women enrolled in the ongoing $100 million Women's
Health Initiative (WHI). Half of these women have been extensively counseled
to consume only 20% of their calories from fat. After 3 years on this
near-draconian regime, say WHI sources, the women had lost, on average, a
The link between dietary fat and heart disease is more complicated, because
the hypothesis has diverged into two distinct propositions: first, that
lowering cholesterol prevents heart disease; second, that eating less fat
not only lowers cholesterol and prevents heart disease but prolongs life.
Since 1984, the evidence that cholesterol-lowering drugs are
beneficial--proposition number one--has indeed blossomed, at least for those
at high risk of heart attack. These drugs reduce serum cholesterol levels
dramatically, and they prevent heart attacks, perhaps by other means as
well. Their market has now reached $4 billion a year in the United States
alone, and every new trial seems to confirm their benefits.
The evidence supporting the second proposition, that eating less fat makes
for a healthier and longer life, however, has remained stubbornly ambiguous.
If anything, it has only become less compelling over time.
Indeed, since Ancel Keys started advocating low-fat diets almost 50 years
ago, the science of fat and cholesterol has evolved from a simple story into
a very complicated one. The catch has been that few involved in this
business were prepared to deal with a complicated story. Researchers
initially preferred to believe it was simple--that a single unwholesome
nutrient, in effect, could be isolated from the diverse richness of human
diets; public health administrators required a simple story to give to
Congress and the public; and the press needed a simple story--at least on
any particular day--to give to editors and readers in 30 column inches. But
as contrarian data continued to accumulate, the complications became
increasingly more difficult to ignore or exclude, and the press began
waffling or adding caveats. The scientists then got the blame for not
sticking to the original simple story, which had, regrettably, never
More fats, fewer answers The original simple story in the 1950s was that
high cholesterol levels increase heart disease risk. The seminal Framingham
Heart Study, for instance, which revealed the association between
cholesterol and heart disease, originally measured only total serum
cholesterol. But cholesterol shuttles through the blood in an array of
packages. Low-density lipoprotein particles (LDL, the "bad" cholesterol)
deliver fat and cholesterol from the liver to tissues that need it,
including the arterial cells, where it can lead to atherosclerotic plaques.
High-density lipoproteins (HDLs, the "good" cholesterol) return cholesterol
to the liver. The higher the HDL, the lower the heart disease risk. Then
there are triglycerides, which contain fatty acids, and very low density
lipoproteins (VLDLs), which transport triglycerides.
All of these particles have some effect on heart disease risk, while the
fats, carbohydrates, and protein in the diet have varying effects on all
these particles. The 1950s story was that saturated fats increase total
cholesterol, polyunsaturated fats decrease it, and monounsaturated fats are
neutral. By the late 1970s--when researchers accepted the benefits of
HDL--they realized that monounsaturated fats are not neutral. Rather, they
raise HDL, at least compared to carbohydrates, and lower LDL. This makes
them an ideal nutrient as far as cholesterol goes. Furthermore, saturated
fats cannot be quite so evil because, while they elevate LDL, which is bad,
they also elevate HDL, which is good. And some saturated fats--stearic acid,
in particular, the fat in chocolate--are at worst neutral. Stearic acid
raises HDL levels but does little or nothing to LDL. And then there are
trans fatty acids, which raise LDL, just like saturated fat, but also lower
HDL. Today, none of this is
controversial, although it has yet to be reflected in any Food Guide
To understand where this complexity can lead in a simple example, consider a
steak--to be precise, a porterhouse, select cut, with a half-centimeter
layer of fat, the nutritional constituents of which can be found in the
Nutrient Database for Standard Reference at the USDA Web site. After
broiling, this porterhouse reduces to a serving of almost equal parts fat
and protein. Fifty-one percent of the fat is monounsaturated, of which
virtually all (90%) is oleic acid, the same healthy fat that's in olive oil.
Saturated fat constitutes 45% of the total fat, but a third of that is
stearic acid, which is, at the very least, harmless. The remaining 4% of the
fat is polyunsaturated, which also improves cholesterol levels. In sum, well
over half--and perhaps as much as
70%--of the fat content of a porterhouse will improve cholesterol levels
compared to what they would be if bread, potatoes, or pasta were consumed
instead. The remaining 30% will raise LDL but will also raise HDL.
All of this suggests that eating a porterhouse steak rather than
carbohydrates might actually improve heart disease risk, although no
nutritional authority who hasn't written a high-fat diet book will say this
As for the scientific studies, in the years since the 1984 consensus
conference, the one thing they have not done is pile up evidence in support
of the low-fat-for-all approach to the public good. If anything, they have
added weight to Ahrens's fears that there may be a downside to
populationwide low-fat recommendations. In
1986, for instance, just 1 year after NIH launched the National Cholesterol
Education Program, also advising low-fat diets for everyone over 2 years
old, epidemiologist David Jacobs of the University of Minnesota, Twin
Cities, visited Japan. There he learned that Japanese physicians were
advising patients to raise their cholesterol levels, because low cholesterol
levels were linked to hemorrhagic stroke. At the time, Japanese men were
dying from stroke almost as frequently as American men were succumbing to
heart disease. Back in Minnesota, Jacobs looked for this
low-cholesterol-stroke relationship in the MRFIT data and found it there,
too. And the relationship transcended stroke: Men with very low cholesterol
levels seemed prone to premature death; below 160 milligrams per deciliter
(mg/dl), the lower the cholesterol level, the shorter the life.
Jacobs reported his results to NHLBI, which in 1990 hosted a conference to
discuss the issue, bringing together researchers from 19 studies around the
world. The data were consistent: When investigators tracked all deaths,
instead of just heart disease deaths, the cholesterol curves were U-shaped
for men and flat for women. In other words, men with cholesterol levels
above 240 mg/dl tended to die prematurely from heart disease. But below 160
mg/dl, the men tended to die prematurely from cancer, respiratory and
digestive diseases, and trauma. As for women, if anything, the higher their
cholesterol, the longer they lived (see graph on p. 2540).
These mortality data can be interpreted in two ways. One, preferred by
low-fat advocates, is that they cannot be meaningful. Rifkind, for instance,
told Science that the excess deaths at low cholesterol levels must be due to
preexisting conditions. In other words, chronic illness leads to low
cholesterol levels, not vice versa. He pointed to the 1990 conference report
as the definitive document on the issue and as support for his argument,
although the report states unequivocally that this interpretation is not
supported by the data.
The other interpretation is that what a low-fat diet does to serum
cholesterol levels, and what that in turn does to arteries, may be only one
component of the diet's effect on health. In other words, while low-fat
diets might help prevent heart disease, they might also raise susceptibility
to other conditions. This is what always worried Ahrens. It's also one
reason why the American College of Physicians, for instance, now suggests
that cholesterol reduction is certainly worthwhile for those at high,
short-term risk of dying of coronary heart disease but of "much smaller or
... uncertain" benefit for everyone else.
This interpretation--that the connection between diet and health far
transcends cholesterol--is also supported by the single most dramatic
diet-heart trial ever conducted: the Lyon Diet Heart Study, led by Michel de
Lorgeril of the French National Institute of Health and Medical Research
(INSERM) and published in Circulation in February 1999. The investigators
randomized 605 heart attack survivors, all on cholesterol-lowering drugs,
into two groups. They counseled one to eat an AHA "prudent diet," very
similar to that recommended for all Americans. They counseled the other to
eat a Mediterranean-type diet, with more bread, cereals, legumes, beans,
vegetables, fruits, and fish and less meat. Total fat and types of fat
differed markedly in the two diets, but the HDL, LDL, and total cholesterol
levels in the two groups remained virtually identical. Nonetheless, over
4 years of follow-up, the Mediterranean-diet group had only 14 cardiac
deaths and nonfatal heart attacks compared to 44 for the "Western-type" diet
group. The likely explanation, wrote de Lorgeril and his colleagues, is that
the "protective effects [of the Mediterranean diet] were not related to
serum concentrations of total, LDL or HDL cholesterol."
Many researchers find the Lyon data so perplexing that they're left
questioning the methodology of the trial.
Nonetheless, says NIH's Harlan, the data "are very provocative. They do
bring up the issue of whether if we look only at cholesterol levels we
aren't going to miss something very important." De Lorgeril believes the
diet's protective effect comes primarily from omega-3 fatty acids, found in
seed oils, meat, cereals, green leafy vegetables, and fish, and from
antioxidant compounds, including vitamins, trace elements, and flavonoids.
He told Science that most researchers and journalists in the field are
prisoners of the "cholesterol paradigm."
Although dietary fat and serum cholesterol "are obviously connected," he
says, "the connection is not a robust one" when it comes to heart disease.
Dietary trade-offs One inescapable reality is that death is a trade-off, and
so is diet. "You have to eat something," says epidemiologist Hugh Tunstall
Pedoe of the University of Dundee, U.K., spokesperson for the 21-nation
Monitoring Cardiovascular Disease Project run by the World Health
Organization. "If you eat more of one thing, you eat a lot less of something
else. So for every theory saying this disease is caused by an excess in x,
you can produce an alternative theory saying it's a deficiency in y." It
would be simple if, say, saturated fats could be cut from the diet and the
calories with it, but that's not the case. Despite all expectations to the
contrary, people tend to consume the same number of calories despite
whatever diet they try. If they eat less total fat, for instance, they will
eat more carbohydrates and probably less protein, because most protein comes
in foods like meat that also have considerable amounts of fat.
This plus-minus problem suggests a different interpretation for virtually
every diet study ever done, including, for instance, the kind of
metabolic-ward studies that originally demonstrated the ability of saturated
fats to raise cholesterol. If researchers reduce the amount of saturated fat
in the test diet, they have to make up the calories elsewhere. Do they add
polyunsaturated fats, for instance, or add carbohydrates? A single
carbohydrate or mixed carbohydrates? Do they add green leafy vegetables, or
do they add pasta? And so it goes. "The sky's the limit," says nutritionist
Alice Lichtenstein of Tufts University in Boston. "There are a million
These trade-offs also confound the kind of epidemiological studies that
demonized saturated fat from the
1950s onward. In particular, individuals who eat copious amounts of meat and
dairy products, and plenty of saturated fats in the process, tend not to eat
copious amounts of vegetables and fruits. The same holds for entire
populations. The eastern Finns, for instance, whose lofty heart disease
rates convinced Ancel Keys and a generation of researchers of the evils of
fat, live within 500 kilometers of the Arctic Circle and rarely see fresh
produce or a green vegetable. The Scots, infamous for eating perhaps the
least wholesome diet in the developed world, are in a similar fix. Basil
Rifkind recalls being laughed at once on this point when he lectured to
Scottish physicians on healthy diets: "One said, 'You talk about increasing
fruits and vegetable consumption, but in the area I work in there's not a
single grocery store.' " In both cases, researchers joke that the only green
leafy vegetable these populations consume regularly is tobacco. As for the
purported benefits of the
widely hailed Mediterranean diet, is it the fish, the olive oil, or the
fresh vegetables? After all, says Harvard epidemiologist Dimitrios
Trichopoulos, a native of Greece, the olive oil is used either to cook
vegetables or as dressing over salads. "The quantity of vegetables consumed
is almost a pound [half a kilogram] a day," he says, "and you cannot eat it
without olive oil. And we eat a lot of legumes, and we cannot eat legumes
without olive oil."
Indeed, recent data on heart disease trends in Europe suggest that a likely
explanation for the differences between countries and over time is the
availability of fresh produce year-round rather than differences in fat
intake. While the press often plays up the French paradox--the French have
little heart disease despite seemingly high saturated fat consumption--the
real paradox is throughout Southern Europe, where heart disease death rates
have steadily dropped while animal fat consumption has steadily risen, says
University of Cambridge epidemiologist John Powles, who studies national
disease trends. The same trend appears in Japan. "We have this idea that
it's the Arcadian past, the life in the village, the utopia that we've
lost," Powles says; "that the really protective Mediterranean diet is what
people ate in the 1950s." But that notion isn't supported by the data: As
these Mediterranean nations became more affluent, says Powles, they began to
eat proportionally more meat and
with it more animal fat. Their heart disease rates, however, continued to
improve compared to populations that consumed as much animal fat but had
less access to fresh vegetables throughout the year. To Powles, the antifat
movement was founded on the Puritan notion that "something bad had to have
an evil cause, and you got a heart attack because you did something wrong,
which was eating too much of a bad thing, rather than not having enough of a
The other salient trade-off in the plus-minus problem of human diets is
carbohydrates. When the federal government began pushing low-fat diets, the
scientists and administrators, and virtually everyone else involved, hoped
that Americans would replace fat calories with fruits and vegetables and
legumes, but it didn't happen. If nothing else, economics worked against it.
The food industry has little incentive to advertise nonproprietary items:
broccoli, for instance. Instead, says NYU's Nestle, the great bulk of the
$30-billion-plus spent yearly on food advertising goes to selling
carbohydrates in the guise of fast food, sodas, snacks, and candy bars. And
carbohydrates are all too often what Americans eat.
Carbohydrates are what Harvard's Willett calls the flip side of the calorie
trade-off problem. Because it is exceedingly difficult to add pure protein
to a diet in any quantity, a low-fat diet is, by definition, a
high-carbohydrate diet--just as a low-fat cookie or low-fat yogurt are, by
definition, high in carbohydrates.
Numerous studies now suggest that high-carbohydrate diets can raise
triglyceride levels, create small, dense LDL particles, and reduce HDL--a
combination, along with a condition known as "insulin resistance," that
Stanford endocrinologist Gerald Reaven has labeled "syndrome X." Thirty
percent of adult males and 10% to
15% of postmenopausal women have this particular syndrome X profile, which
is associated with a several-fold increase in heart disease risk, says
Reaven, even among those patients whose LDL levels appear otherwise normal.
Reaven and Ron Krauss, who studies fats and lipids at Lawrence Berkeley
National Laboratory in California, have shown that when men eat
high-carbohydrate diets their cholesterol profiles may shift from normal to
syndrome X. In other words, the more carbohydrates replace saturated fats,
the more likely the end result will be syndrome X and an increased heart
disease risk. "The problem is so clear right now it's almost a joke," says
Reaven. How this balances out is the unknown. "It's a bitch of a question,"
says Marc Hellerstein, a nutritional biochemist at the University of
California, Berkeley, "maybe the great public health nutrition question of
The other worrisome aspect of the carbohydrate trade-off is the possibility
that, for some individuals, at least, it might actually be easier to gain
weight on low-fat/high-carbohydrate regimens than on higher fat diets. One
of the many factors that influence hunger is the glycemic index, which
measures how fast carbohydrates are broken down into simple sugars and moved
into the bloodstream. Foods with the highest glycemic index are simple
sugars and processed grain products like pasta and white rice, which cause a
rapid rise in blood sugar after a meal. Fruits, vegetables, legumes, and
even unprocessed starches--pasta al dente, for instance--cause a much slower
rise in blood sugar. Researchers have hypothesized that eating high-glycemic
index foods increases hunger later because insulin overreacts to the spike
in blood sugar. "The high insulin levels cause the nutrients from the meal
to get absorbed and very avidly stored away, and once they are, the body
can't access them," says
David Ludwig, director of the obesity clinic at Children's Hospital Boston.
"The body appears to run out of fuel." A few hours after eating, hunger
If the theory is correct, calories from the kind of processed carbohydrates
that have become the staple of the American diet are not the same as
calories from fat, protein, or complex carbohydrates when it comes to
controlling weight. "They may cause a hormonal change that stimulates hunger
and leads to overeating," says Ludwig, "especially in environments where
food is abundant. ..."
In 1979, 2 years after McGovern's committee released its Dietary Goals,
Ahrens wrote to The Lancet describing what he had learned over 30 years of
studying fat and cholesterol metabolism: "It is absolutely certain that no
one can reliably predict whether a change in dietary regimens will have any
effect whatsoever on the incidence of new events of [coronary heart
disease], nor in whom." Today, many nutrition researchers, acknowledging the
complexity of the situation, find themselves siding with Ahrens. Krauss, for
instance, who chairs the AHA Dietary Guidelines Committee, now calls it
"scientifically naïve" to expect that a single dietary regime can be
beneficial for everybody: "The 'goodness' or 'badness' of anything as
complex as dietary fat and its subtypes will ultimately depend on the
context of the individual."
Given the proven success and low cost of cholesterol-lowering drugs, most
physicians now prescribe drug treatment for patients at high risk of heart
disease. The drugs reduce LDL cholesterol levels by as much as
30%. Diet rarely drops LDL by more than 10%, which is effectively trivial
for healthy individuals, although it may be worth the effort for those at
high risk of heart disease whose cholesterol levels respond well to it.
The logic underlying populationwide recommendations such as the latest USDA
Dietary Guidelines is that limiting saturated fat intake--even if it does
little or nothing to extend the lives of healthy individuals and even if not
all saturated fats are equally bad--might still delay tens of thousands of
deaths each year throughout the entire country. Limiting total fat
consumption is considered reasonable advice because it's simple and easy to
understand, and it may limit calorie intake. Whether it's scientifically
justifiable may simply not be relevant.
"When you don't have any real good answers in this business," says Krauss,
"you have to accept a few not so good ones as the next best thing."
Natural Health Newsletter
Randall Neustaedter OMD
Here they go again
Those bad boys at the drug companies are at it again. First they lower the
normal cholesterol recommendations from 220 to 200 and then 180. Wow have
the sales for Lipitor and other statin-type cholesterol- lowering drugs been
soaring. That amounts to a lot of bucks $$$$ for the drug industry, despite
all those pesky lawsuits for the deaths caused by Baycol, which was taken
off the market. Watch out for those side effects, including liver damage.
They can get you faster than cholesterol-related heart disease.
Now a new decree has lowered the numbers for blood pressure as well. Brace
yourselves for a barrage of advertisements for blood pressure medications
because all of you who thought you had normal blood pressures of 120/80 are
now classified with a disease called pre-hypertension as of the announcement
on May 15, 2003. You thought 140/90 was the upper limit of normal didn't
you? Not anymore. The current recommendation (this week) is to treat anyone
with prehypertension and other complicating diseases such as diabetes or
kidney problems with drugs. The rest of us can expect to get lectures about
losing weight, exercise, and low fat diets.
Doctors Appeal to free Innocent Incarcerated "Munchausen"
Roanoke, VA 24014 May 20, 2003
More than five years after her wrongful prosecution for death and injury to
her children in 1981-82 a mother remains behind bars in West Virginia for
reasons known only to those maintaining injustice under color of law.
Signed by doctors who have examined specimens (some still emerging years
post-trial), who know their science and support failure to prosecute
initially because both children shared a metabolic disorder, a second appeal
for clemency letter from Citizens to Free Marybeth Davis was sent May 15
(2003) to Gov. Wise.
The first letter was mailed Feb. 1, 2002.
"Tegan was not murdered and there was no attempt to murder Seth. The
confirmed diagnosis for Tegan is Reyes Syndrome, a condition to which it is
now thought she was predisposed by a genetic metabolic (birth) defect. The
confirmed diagnosis for Seth is Human Growth Hormone Deficiency (HGHD),
formally included under the general name of Leighs Syndrome, a genetic
metabolic (birth) defect that causes, amongst other things, reoccurring
episodes of hypoglycemia," the correspondence appeal reminds the state's top
Adding a major fact that took years of frustrating effort to find in medical
files withheld from defense, the letter reveals "It has also been discovered
that Seth suffered brain damage due to lack of oxygen when his endotracheal
tube became displaced on the helicopter flight to Pennsylvania.
"However, the courts do not acknowledge the existence of these diagnoses of
natural causes made and confirmed by licensed physicians, and they continue
year after year with their legal procedures, pretending to be oblivious to
the fact that no crimes were committed and that the September 1997 trial was
totally in error."
The latest appeal letter and other evidence and court documentation can be
found at Click here: Free Marybeth Davis
Stating a reasonable conclusion remaining in the aftermath of the stunning
1997 trial result--life without mercy for Marybeth--the letter's next
paragraph notes: "Dr. Joseph Aldrich, the attending physician for both Tegan
and Seth and an eyewitness, told former Greenbrier County prosecutor, Mark
Burnette, prior to the trial, that he and other doctors in 1981-82 had
determined that the health problems of the children were due to natural
causes and that no murder or attempted murder had been committed.
"From all indications, the former prosecutor simply chose to ignore this
information and went to trial knowing that there was no proof that the
suspected crimes had been committed. That was either gross stupidity or
deliberate wrong doing."
To fast-forward to current events, during his second and ultimately
successful bid for election to the West Virginia Senate, former prosecutor
Burnette mentioned his success in convicting Marybeth Davis in his
Ten months before his belated trial of the stunned mother the prosecutor
regaled media which treated the public to emotive speculation about supposed
"new evidence." Although the innocent mother was never evaluated for or
diagnosed with the still scientifically baseless motivation theory--coined
name "Munchausen Syndrome by Proxy"-- it had been accepted by careless
courts fairly soon after publication of Dr. Roy Meadow's "Hinterlands"
article in August 1977, years prior to the illness and death of the Davis
Careful reading of the MSP theory shows Dr. Meadow admitting to saltloading
a frequently ill baby in the United Kingdom. The infant always was admitted
with high salt levels shown by lab findings. By the doctor's own words his
actions were not a standard treatment, not an accident, and not approved or
consented research. That is how MSP motivation theory began. It could end in
West Virginia if Gov. Wise reads more carefully, than did local prosecutors
and the Greenbrier County Court, Sir Roy Meadow's nearly 26-year-old bold
confession at: http://web.tiscali.it/humanrights/articles/meadow77.html
Putting in the fewest possible words the prosecution's route to wrongful
conviction, the letter continues: "The former prosecutor then convinced an
uneducated jury that, contrary to common sense and medical findings,
Marybeth had committed murder/attempted murder because she fit the profile
for a parent with Munchausen Syndrome By Proxy, a hypothetical and highly
controversial psychiatric condition that is not recognized as legitimate by
the American Medical Association or the American Psychiatric Association.
"In the final analysis, Marybeth was convicted of committing an imaginary
murder (with the amount of caffeine in a cup of coffee as the supposed
murder weapon) because she was suspected of having an imaginary psychiatric
disorder. The absurdity of this tragedy boggles the mind, and illustrates,
once again, that modern medicine and common sense are not a match for
ignorance." With the story behind the story still unfolding--just why it
appears vital for those with official and personal interests to leave an
innocent mother in prison--the letter alludes to the former Illinois
governor's freeing wrongly convicted innocents and urges similar action by
"More than five years after the trial for crimes that did not happen, the
West Virginia Courts refuse to acknowledge that they put an innocent woman
in prison whose children suffered from metabolic birth defects. We suspect
that the authorities involved are now trying to cover up their mistake by
delaying Marybeth's release from prison for as long as possible." "Citizens
to Free Marybeth Davis is once again asking that you do that which is
morally right, acknowledge the absence of crimes and the existence of the
medical diagnoses of natural causes for the alleged victims, and order
Marybeth released from prison.
"She is not guilty of poisoning her children because her children were not
poisoned. If the Governor of Illinois can order the release of falsely
convicted people from prison in his state, you should be able to do the same
for a person who was convicted without crimes in West Virginia," the letter
concludes. After the tragic death of their daughter and the truly "new
evidence" of injury to and more recently the death of their son, Marybeth
and her husband adopted a lovely daughter and had a son, today healthy
teens. Her attorney--now pressing her case into a third exhausting
decade--is Paul Detch of Lewisburg, W. Va.
For more on MSP see also
and another mother's story at
Barbara Bryan (BHBryan@aol.com)
National Child Abuse Defense & Resource Center
P.O. Box 8323
Roanoke, VA 24014
Phone : 540-345-1952
Fax : 540-345-1899
Suit Says Drugs Made From Tainted Blood
Tue Jun 3, 2:56 PM ET Add Top Stories - AP to My Yahoo!
By KIM CURTIS, Associated Press Writer
SAN FRANCISCO - Several hemophiliacs filed a lawsuit against Bayer Corp. and
other companies, claiming they exposed patients to HIV (news - web sites)
and hepatitis C by selling medicine made with blood from sick, high-risk
donors. The lawsuit alleges the companies continued distributing the
blood-clotting product in Asia and Latin America in 1984 and 1985, even
after they stopped selling it in the United States because of the known risk
of HIV and hepatitis transmission.
The lawsuit filed Monday in federal court seeks class-action status on
behalf of thousands of foreign hemophiliacs who received the product, said
attorney Robert Nelson. It accuses the companies of negligence and
fraudulent concealment. "This is a worldwide tragedy," Nelson said.
"Thousands of hemophiliacs have unnecessarily died from AIDS (news - web
sites) and many thousands more are infected with HIV or hepatitis C."
Bayer rejected the claims, saying in a statement from its headquarters in
Leverkusen, Germany Tuesday that it would examine the lawsuit and prepare
its defense. "Bayer at all times complied with all regulations in force in
the relevant countries based on the amount of scientific evidence available
at the time," the company said, adding that decisions made 20 years ago
should not be judged by today's scientific knowledge.
Nelson said the lawsuit was filed in California because defendant Cutter
Biological, now a division of Bayer, was formerly based in Berkeley. Several
plasma donation sites also were located in the San Francisco Bay area, he
said. The lawsuit was filed less than two weeks after an investigation by
The New York Times accused the company of selling old stock of the medicine
abroad, while marketing a newer, safer product in the United States.
Bayer told Times it sold the old medicine because some customers doubted the
effectiveness of a new version of the product, and because some countries
were slow to approve its sale. While the company said it acted responsibly
and in line with the best medical knowledge at the time, Bayer and three
other companies that made the concentrate settled 15 years of U.S. lawsuits
from people who took the drug, paying about $600 million.
The medicine, called Factor VIII concentrate, can stop or prevent
potentially fatal bleeding in people with hemophilia. Early in the AIDS
epidemic, the medicine was commonly made using mingled plasma from 10,000 or
more donors. Because there was not yet a screening test for HIV, the virus
that causes AIDS, thousands of hemophiliacs were infected.
But the lawsuit alleges Bayer and the others refused to take precautions
that could have made the product safer. As of 1992, the contaminated blood
products had infected at least 5,000 hemophiliacs in Europe with HIV. More
than 2,000 had already developed AIDS and 1,250 had died from the disease,
the lawsuit said. By the mid-1990s in Japan, hemophiliacs accounted for the
majority of the country's 4,000 reported cases of HIV infection and
virtually all infections of Japan's hemophiliacs have been linked to
contaminated blood products imported from the United States, the lawsuit
said. In Latin America, at least 700 HIV cases are linked to use of
contaminated blood products by hemophiliacs, the lawsuit said.
Patients used as drug 'guinea pigs'
Firms pay out millions to doctors to test medicines
Antony Barnett, public affairs editor
Sunday February 9, 2003
When Italia Sudano went for a check-up with her GP, Dr Robert Adams, she was
in good health. Her husband had died a few months earlier and her blood
pressure was a little high. Yet nothing could have prepared Sudano, 72, for
the nightmare that was to follow and the discovery of a trail of greed and
fraud that went right to the heart of the medical profession.
She was astonished to discover that her trusted GP had been using her as a
guinea pig by giving her tablets which had not been medically approved.
Worse still, he was being paid to do so by a pharmaceutical company. An
investigation by The Observer has revealed that many doctors are risking
their patients' health by subjecting them to medical trials without their
Sudano's ordeal began when Adams took a blood test and asked her to return
the next week. She had been living at Letchworth in Hertfordshire since
arriving from Italy 50 years earlier and she trusted British doctors.
Over the next few weeks Adams asked Sudano to return for more blood tests.
By the end of the second month her arms were black and blue. Her son, Joe,
said they looked as though they had been slammed in a
door. She said: 'At one point I asked if he was selling my blood.' Little
did Sudano know how close to the truth her comment was. On her last visit,
Adams took a bottle of pills from the top drawer of his desk and suggested
Sudano take one a day. While she thought it strange she wasn't being given a
prescription, she trusted her doctor.
But within hours of swallowing the pill, she could hardly walk because she
was so dazed. Her face had swollen up badly and she was in considerable
pain. She stopped taking the tablets and complained to Hertfordshire Health
Authority. This sparked an investigation that led to one of the largest
cases of medical research fraud ever uncovered in Britain.
It emerged that over the previous five years Adams had earned more than
£100,000 from drug companies, including the European giants AstraZeneca,
GlaxoSmithKline and Bayer. They were all paying him to test their new drugs
on his patients. Like Sudano, many of his patients had never given their
consent and had no knowledge they were being used as human guinea pigs in a
medical trial. Patients with no symptoms were given drugs and others who
needed proper medication were given placebos. Adams was receiving almost
£1,000 for each patient.
Last month Adams was found guilty by the General Medical Council (GMC) of
serious professional misconduct and suspended for 12 months. The GMC's
lawyer described it as 'assault' and Sudano is now looking to sue Adams.
GlaxoSmithKline was using Adams to study its anti-depressant Paroxetine,
but had to cancel the trial at a cost of hundreds of thousands of pounds.
The drugs industry talks of bad apples and the odd errant doctor milking the
system but insists that trials using GPs are essential for medical advances
and that payment to doctors for the extra work involved is ethically
But an investigation by The Observer suggests the problem of GPs using
patients as guinea pigs without their consent is more widespread. Some 3,000
doctors each year are paid by drug firms to sign up their patients to tests
and on average 15 patients are needed for each trial. With doctors picking
up £1,000 per patients drug companies are spending £45m on getting doctors
onside. There is no suggestion the companies are implicated in moves to
carry out the tests by doctors on patients secretly.
Medical fraud experts estimate that one per cent of all drug trials involve
fraud, including failure to get proper consent from patients. This means
hundreds of patients a year are being given unapproved and potentially
dangerous drugs without their knowledge.
The Observer has discovered that in the last five years the GMC has taken
action in a dozen cases involving GPs undertaking fraudulent research.
· Dr Vasu Agrawal from Chigwell, Essex, removed samples of womb from
menopausal women as part of a trial into a new hormone replacement drug
called Divina Nova. Agrawal failed to tell the women they were testing a
drug that could have serious side-effects. Agrawal, who forged signatures on
consent forms, received almost £6,000 from Orion Pharma International.
· Dr Paul Chima from Edinburgh is estimated to have received more than
£200,000 from a range of pharmaceutical companies for testing their new
drugs for angina, asthma, high blood pressure and depression. He failed to
warn patients of possible side-effects and offered one a £2,000 bribe not to
give evidence against him.
· Dr James Boschler from south London was given £22,500 from Bayer and
Solvay Healthcare. He claimed to have signed up 36 patients, but 25 of the
consent forms were discovered to be forgeries.
The country's foremost investigator of medical research fraud is Peter Jay,
the former Metropolitan Police detective chief inspector who arrested serial
killer Dennis Nilsen. Since 1996 Jay has run MedicoLegal Investigations, an
independent body, and has taken 12 doctors to the GMC.
Jay is investigating six further cases, including one involving a GP in
Manchester. Dr Mark Northfield is alleged not to have obtained consent from
patients for entering them into trials to test drugs manufactured by Bayer
and Roche to treat high blood pressure and heart problems. Northfield is
contesting the allegations before the GMC professional conduct committee.
Jay said: 'While the industry has become more alert to the problems over the
last decade there is still clearly a worrying and persistent problem in
research fraud involving doctors. This is not just an issue of patient
safety, but a problem that might lead to bad drugs being approved or good
drugs failing to be approved.'
The Observer's revelations of the continuing problem of research fraud have
sparked calls for industry guidelines to be toughened up. David Hinchcliffe,
the Labour chair of the House of Commons Health Select Committee, described
the situation as bordering on 'scandalous' and said his committee would look
into the issue.
He said: 'The relationship between the drug firms and the medical
profession is one that needs to be thoroughly investigated. It is extremely
worrying that patients' trust is being abused by doctors who are more
interested in making money from the pharmaceutical industry.'
Dr Evan Harris, health spokesman for the Liberal Democrats, suggested that
doctors involved in trials should be subject to on-the-spot inspections and
that a patient's consent to take part in a drug trial should be given
outside the GP's surgery, for example to a research officer acting for the
Additional research by Charlotte Coulon
16 die in hospital 'by
SIXTEEN people reportedly died in Victorian hospitals due to medical
mistakes last financial year, including a child who was given the wrong
medication. Almost a dozen other people suffered injury due to medical
staff treating the wrong patient or body part, instruments being left behind
after surgery and neurological damage according to documents The Age has
Five more patients reportedly committed suicide in hospital. The deaths and
injuries reported to the State Government in 2002-03 - the second year
details of such mistakes have been supplied - are regarded as only a small
number of those that actually take place. "It's still a relatively low
proportion of the major incidents and deaths that are occurring," said
Michael Walsh, chief executive of Bayside Health - which covers hospitals
including the Alfred - and deputy chair of the Australian Council for Safety
and Quality in Health Care, a body set up in 2000 by federal and state
health ministers. "The reality is that hospitals have an appreciable element
of risk about them, particularly for folk with complex care needs, who are
quite old, and come through the emergency department," he said. Documents
detailing the events, obtained under freedom of information laws, did not
disclose which hospitals were involved or information that might identify
patients, the paper said. This report appears on news.com.au.
Immunity's Memories, Lost and Found
Discovery of peripheral effector T cells dismantles the lymphoid tissue
By Josh P. Roberts
Courtesy of Mark Jenkins
SLICED MICE: Single-cell-thick sections of adult mice expressing CD45.1
stained with nuclear dye (blue) and a monoclonal antibody specific for
CD45.2 (red). The left panel shows a background level of CD45.2 staining.
The center panel shows a mouse that received several million Salmonella
peptide-specific CD4 T cells from a transgenic mouse expressing CD45.2.
Transferred naïve T cells were found only in secondary lymphoid organs. At
right, when also injected with Salmonella peptide three days prior to
staining, CD4 T cells proliferated and migrated into nonlymphoid
Scientists have long believed that immunological memory--the record of
infections past--is maintained by highly differentiated T cells and B cells
that were generally thought to reside in the spleen and lymph nodes, the
secondary lymphoid organs. Thus, the lymph nodes and blood (considered a
surrogate for the spleen) are typically used to probe the long-term effects
of immunological challenge. But as it turns out, these memory seekers may
have been looking in all the wrong places. In this issue's Hot Papers, two
research teams, using different but complementary techniques, discovered
that nonlymphoid tissues such as the lungs and fat pads also harbor memory T
cells. These cells seem to respond to antigenic rechallenge differently than
their counterparts in the spleen and lymph nodes.
Data derived from the Science Watch/Hot Papers database and the Web of
Science (ISI, Philadelphia) show that Hot Papers are cited 50 to 100 times
more often than the average paper of the same type and age.
D. Masopust et al., "Preferential localization of effector memory cells in
nonlymphoid tissue," Science, 291:2413-7, 2001. (Cited in 195 papers)
R.L. Reinhardt et al., "Visualizing the generation of memory CD4 T cells in
the whole body," Nature, 410:101-5, 2001. (Cited in 175 papers)
"The magnitude of the populations of memory cells that you could find in
these nonlymphoid tissues hadn't been appreciated," says Leo Lefrançois, of
the University of Connecticut Health Center in Farmington and a principle
investigator on one paper.1 "Our data showed that probably an equal number,
if not a greater number, of memory cells were found in the nonlymphoid
tissues at any time during the response to infection as there were in the
lymphoid tissue." What Lefrançois' team found for CD8+ (cytotoxic) T cells,
Marc Jenkins' University of Minnesota-Twin Cities team found for CD4+
(helper) T lymphocytes.2 The findings, says Jenkins, "really forced people
to consider nonlymphoid tissue as a reservoir of memory cells." And that,
says Susan Swain, director of the Trudeau Institute in Saranac Lake, NY, is
one of the reasons that so many of her fellow immunologists have paid
attention to the papers. "They didn't really think of [T] cells going to
bizarre places like fat pads and other nonlymphoid sites," she says. It had
been known for some time that activated cells, those that had recently
encountered antigen, can migrate throughout the body. But these papers
piqued the immunology community's interest for two reasons: First, not all
the peripheral T cells Lefrançois and Jenkins looked at expressed the
phenotypic markings of activation. Second, many had the characteristics of
effector cells, which provide help to cytotoxic or phagocytic cells, or are
themselves cytotoxic, much more so than even those seen in lymphoid tissues.
VISUALLY STUNNING RESULTS In the years leading up to these publications,
many labs had seen that the clonal expansion of T cells responding to an
immunization peaked at about five to seven days. This was followed by a
dramatic loss of antigen-specific cells from the lymphoid tissue, and
finally stabilization in cell numbers. "We were wondering whether that loss
phase could be explained partly, simply by exodus of cells from the lymphoid
tissue into nonlymphoid tissue," Jenkins recalls. "We decided that to make
the accounting exercise complete, we needed to sample the nonlymphoid body."
There were, essentially, two ways to accomplish this goal. One was to "take
out and grind up all the nonlymphoid organs, try to get the cells out, and
see if we could find the antigen-specific cells there," Jenkins explains.
The other was to "use a method that could sample everything at once," which
is what his lab ended up doing. They refined a technique called whole-body
thin sectioning to resolve single antigen-specific T cells. "[First author]
Lee [Reinhardt] worked out a catalytic amplification system that gave him an
intense signal from the primary antibody he was staining with," says
Jenkins. By analyzing multiple sections through different animals, at
different time points, he showed that "many of these cells appear in
nonlymphoid tissue, even though none were there before immunization." The
method is incredibly labor-intensive. Even after he had determined the ideal
conditions for staining, Reinhardt still needed to take about 750 digital
images for eachsection, and "jigsaw all those together in a precise way that
created the total picture," Jenkins, his mentor, explains. "It took him four
years to do that paper, basically." The results were "visually stunning,"
says Graham Le Gros, director of research for New Zealand's Malaghan
Institute. Lefrançois' group took the other route to their findings,
grinding samples from different tissues. They isolated lymphocytes from both
lymphoid and nonlymphoid tissues of
mice that had been previously infected with virus or bacteria, and used flow
cytometry, staining for antigen-specific T-cell receptors and other markers,
to determine the percentages of memory cells in different organs. Even 296
days after infection, virus-specific CD8+ T cells were seen in nonlymphoid
tissues in significant numbers. Says Lefrançois: "We performed a major
cataloging of the immune response to infection throughout the entire body,
which hadn't been done before." CENTRAL AND EFFECTOR MEMORY To the surprise
of Lefrançois and his fellow immunologists, the cells found in the periphery
"had immediate effector function," he says. This helped to prove a
hypothesis put forward a year and a half earlier by Antonio Lanzavecchia and
his colleagues at the Basel Institute for Immunology in Switzerland. The
hypothesis states that there are at least two functional phenotypes of
memory cells.3 In a recent review, Lefrançois explains: "Central memory T
cells are located in the secondary lymphoid tissues, have little cytolytic
activity, and are proposed to have limited migratory potential. Effector
memory T cells reside in nonlymphoid tissues, are cytolytic, and have
promiscuous circulatory potential."4 Meanwhile, Jenkins says he was
surprised to find that peripheral CD4+ cells made interferon-gamma (IFN-*),indicating
that they, too, were effector cells. His group had spent considerable time
analyzing lymphoid tissue, but previously could not find many IFN-*-producing
cells. These cells should be plentiful, given that the mice were making
IgG2a antibodies, an indication of IFN-* production. "Both papers inform us
very clearly that we must look at the behavior of lymphocytes in their true,
most relevant, context: peripheral tissues," says Le Gros. All the paradigms
have been built up based on lymph node T cells, but behavior and properties
of lymphocytes in peripheral tissues cannot be ignored. They are "very
disease-relevant, and very relevant to the design of vaccines," Le Gros
adds. When physicians or vaccine designers such as the National Institutes
of Health's Robert Sedar want an indication of the human response to
immunization, they typically look for effector cytokines such as IFN-* or
interleukin-4 (IL-4), but only in the circulating lymphocytes. "So we're
massively underestimating, probably, the effector response by limiting
ourselves in humans just to blood," Sedar says. Lefrançois' and Jenkins'
work "opened our eyes." Le Gros says that in his studies of asthma, much
drug discovery is aimed at controlling the activation and proliferation of T
cells in a lymph-node context, but this may be wrong. He and his colleagues
have recently reported that activated T cells in the lymph nodes can migrate
to the lung and airway. Once there, while able to produce considerable
amounts of the asthmatic cytokine IL-4 upon antigenic challenge, they are
completely unable to divide or migrate back to the lymph nodes.5 Swain's
group has found that "there is continuum of effector heterogeneity, and only
the most differentiated effectors can migrate into an inflammatory" or other
nonlymphoid site.6 They suggest that these "heterogeneous effector
populations may give rise to corresponding memory populations."7 The raison
d'etre for extralymphatic effector lymphocytes is easy to guess. It just
makes sense for antigen-specific effector cells to be where an infection is
likely to recur. Many researchers now are teasing out additional differences
between these and the cells in the lymphatic organs.
Josh P. Roberts (firstname.lastname@example.org)
is a freelance writer in Minneapolis Minn.
(Note: Marc Jenkins was a member of Roberts' PhD committee at the University
1. D. Masopust et al., "Preferential localization of effector memory cells
nonlymphoid tissue," Science, 291:2413-7, 2001. (Cited in 195 papers)
2. R.L. Reinhardt et al., "Visualizing the generation of memory CD4 T cells
in the whole body," Nature, 410:101-5, 2001. (Cited in 175 papers)
3. F. Sallusto et al., "Two subsets of memory T lymphocytes with distinct
homing potentials and effector functions," Nature, 401:708-12, 1999.
4. K.S. Schluns, L. Lefrançois, "Cytokine control of memory T-cell
development and survival," Nat Rev, 3:269-79, April 2003.
5. N.L. Harris et al., "Differential T cell function and fate in lymph node
and nonlymphoid tissues," J Exp Med, 195:317-26, 2002.
6. S.L. Swain et al., "Regulation of memory CD4 T cells: Generation,localization and persistence," Adv Exp Med Biol, 512:113-20, 2002.
7. E. Roman et al., "CD4 effector T cell subsets in the response to
influenza: heterogeneity, migration, and function," J Exp Med, 196:957-68,
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Contact: Vera Hassner Sharav
To err is human, but Johns Hopkins researchers have shown a tendency to cut
corners on safety and ride roughshod with experimental subjects--human and
This time the victims are 10 monkeys and baboons who died as a result of being
injected with d-amphetamine in an experiment that was testing the toxicity of
Ecstasy. Failure by anyone at the laboratory to examine and properly label the
vials containing d-amphetamine and Ecstasy, resulted in their death. The New
York Times reports that Dr. Richard Ricaurte, the principle investigator said
his laboratory made "a simple human error." "We're scientists, not politicians."
Don't we expect scientists to be meticulous about following proper scientific
methods in the laboratory to protect the safety of the living subjects, not to
mention to ensure the integrity of their findings?
The culture that dominates academia is reflected in the scientist's response to
the reporter's question: why were the vials not checked first? Dr. Ricaurte's
"We're not chemists. We get hundreds of chemicals here. It's not customary to
Is the proper labeling of controlled, Schedule II psychoactive substances a
requirement of FDA regulations?
PHARMOPHILIA: Why Do Doctors Love Drugs So Much?
"Modern medicine" may well be defined as "the experimental study of what happens
when poisonous chemicals are placed into malnourished human bodies." Politically
powerful medical quackery is nothing new. Drug-and-cut doctors have been
ignoring nature's laws for a long time, with disastrous results. "General
Washington was taken in the night (in December, 1799) with a sore throat. The
'bleeder' being sent for, he took from him 14 ounces of blood. The following
morning, the family physician arrived, and proceeded to bleed him copiously,
twice within a few hours, and again the same evening, giving him thereafter a
dose of calomel (mercury). Next morning he was given another dose. The next day
another physician was called in consultation, and the result was that they took
an additional 32 ounces of blood from General Washington. There was no
alleviation of the disease. Ten grains more of calomel were given, followed by a
tartar emetic in large doses. To his extremities blisters were applied, and to
his throat poultices."
"General Washington died."
(from the Pittsburgh Health Club Newsletter, July 31, 1931)
Former First President George Washington, the father of our country, died from a
sore throat? No sir: he died from the treatment. Washington had the best
scientific medical attention of his day. And? They bled him no fewer than five
times in three days. Let's do the grisly arithmetic. The first bleeding removed
14 ounces; there were then three bleedings of unspecified quantity, collectively
described as "copious"; and then a final full quart was removed. Assuming that
the three "copious" bleedings were also 14 ounces each, that is another 42
ounces lost. Adding up, we have:
14 x 3 = 42
Some 88 ounces of blood was taken from George Washington. The human body
contains about 10 units, that is to say 10 pints (5 quarts) of blood. 88 ounces
is pretty close to 3 quarts, or nearly 6 units; that's well over half the blood
in a person. Some estimates place Washington's total bleeding
closer to 8 units. It doesn't take a conspiracy, nor does it require an
assassin, to kill a great man. Stupidity will do it just as well.
"The Dark Ages of Medicine are long over," you say? If only that were true.
Let's take a short hop over to Britain for some very unsettling news that may
well bring avoidable sickness and unnecessary death to millions.
MOST VITAMIN SUPPLEMENTS TO BE BANNED THROUGHOUT EUROPE:
THE EU FOOD SUPPLEMENTS DIRECTIVE
by P.M. Goodwin, United Kingdom
The European Union Food Supplements Directive was passed by the EU Parliament on
13 March 2002, and became law in the 15 EU member states on 1 August 2003.
This legislation, if unchallenged, will have the effect of banning over 300
vitamin and mineral forms and 5000 products from the European market, by 1st
By 2007, if not earlier, the Food Supplements Directive will also be applied to
other nutrient groups such as fatty acids and amino acids, with similarly
devastating results. Other EU legislation currently in the pipeline, such as the
Traditional Herbal Medicinal Products Directive and the Pharmaceuticals
Directive (which proposes to amend the definition of a medicine) threatens to
remove still further categories of natural health products from the European
Readers of this newsletter who live outside of the EU and who think that this
legislation bears no relevance to them should think again. The Food Supplements
Directive bears a strong resemblance to legislation now under discussion at a
global level by the Codex Alimentarius committee (a little known commission of
the United Nations World Trade Organization). Indeed,
many of the architects of the Directive are also members of the Codex committee.
If the Food Supplements Directive is not stopped it will strongly influence the
deliberations of the Codex committee, who advocate similar tight restrictions on
the sale of supplements. The USA would then come under strong international
pressure to implement the Codex recommendations because of its' having signed up
to the NAFTA and GATT international trade agreements. All decisions emanating
from the Codex Alimentarius Commission are directly incorporated by the World
Trade Organization (WTO) and will ultimately overrule all current national laws.
Although many US supplement companies have been led to believe that US laws
cannot be downgraded ("harmonized") to WTO/Codex, close examination of WTO rules
appear to make this almost inevitable; especially so considering the weak
statutory wording of the 1997 FDA Modernization Act, which purports to protect
American health freedoms from harmonization to restrictive rules elsewhere.
The Alliance for Natural Health (ANH)
http://www.alliance-natural-health.org is an international organization of
scientists, practitioners, lawyers, public relations and media experts working
specifically to amend European legislation in order to maintain the availability
of innovative, safe and effective food supplements. While progress has been made
in proposing amendments to the Traditional Herbal Medicinal Products Directive
and the Pharmaceuticals Directive, the time for lobbying in respect of The Food
Supplements Directive is over. The only option remaining now to eliminate the
devastating effects of this Directive is a lawsuit. This is a costly process,
and funds are very urgently needed. Please consider making a donation to the ANH
legal campaign-fund at
Legal papers to challenge the directive have to be filed in London by the end of
October, at the very latest, or our window of opportunity will close. The future
rights of all people on this planet to buy safe and effective dietary
supplements are now at stake, and a choice regarding whether or not we are
prepared to defend these rights must now be made by each and every one of
The Doctor Shrugged
Thursday, October 30, 2003
By Julia Gorin
I find the show "ER" fascinating. On it, the people in white coats actually rush
around as if something is at stake. Their faces show expression, often of
concern, as if they're worried whether a patient lives or dies. It isn't like
any emergency room or doctor's office I've ever seen.
In real life, one goes to a hospital if he or she is curious to have a near
death experience. Medical treatment is the third leading cause of death in the
United States, after heart disease and cancer, according to a 2000 Journal of
the American Medical Association article by Dr. Barbara Starfield (search) of
the Johns Hopkins School of Hygiene and Public Health. Starfield places
medically-related deaths at 225,000 a year, while a more conservative estimate
by a 1999 Institute of Medicine report placed the number of deaths by medical
error at 100,000 a year.
The subsets of statistics behind these numbers are even more alarming.
Starfield's JAMA report claimed that 106,000 deaths are caused by correctly
prescribed medications, while prescription error accounts for 7,000 annual
deaths. (Meanwhile, a 1998 JAMA study claims prescription error seriously
injures 2.1 million patients every year.)
Last week, ABC's "Primetime Thursday" attributed 100,000 annual deaths to
hospital infections alone--at least 50,000 of them preventable through the
practice of basic hygiene by hospitals. The report mentioned that ABC
sportscaster Dick Schaap died two years ago from a hospital infection he got
after routine hip replacement surgery because the medical staff at New York's
prestigious Lenox Hill Hospital couldn't be bothered to wash their hands between
My former college professor, who has a heart condition, caught on early.
Whenever hospital staff enter his room, he asks, "What is my name? And what am I
here for?" Otherwise, he fears, healthy organs may get removed and the wrong
appendages amputated. But even this kind of diligence would not have helped a
former colleague of mine, a 115-pound woman who went into the hospital for a
colonoscopy and wound up in the intensive care unit after being injected with
enough local anesthetic for a 220 pound man.
When I was paying out-of-pocket for an HMO that didn't cover medication, I was
given a prescription for medicine to treat a condition opposite of what I had.
After the mistake was discovered--and after I had paid for and ingested the
pills-- I asked the substitute doctor if I could get reimbursed for the
expensive but incorrect prescription his partner prescribed. He condescendingly
defended the erring doctor saying, "Doctors are only human. We make mistakes.
Haven't you ever made a mistake?" Needless to say, I got a new doctor, an
obstetrician with whom I was very happy until one day, after delivering a
patient's baby via cesarean section, he decided to carve his initials into the
Consider that when medical doctors in Israel went on strike (search) in early
2000, the funeral industry tanked. The burial association complained to the
government to increase doctors' salaries. The only city that did not see a
decline in its death rate was Netanya, where doctors had a no-strike clause in
Doc, when your parents sent you to medical school so you could make a killing,
they didn't mean literally.
The frightening statistics, coupled with the negative doctor-patient experiences
behind them (35 percent of doctors themselves complain about the doctor care
they or their families get, according to the IOM report) might explain why there
is something called alternative medicine (search). It gives people an
alternative to dying.
Don't think I wasn't skeptical when my homeopath told me the pain in my
neck was being caused by a troubled gall bladder. But sure enough, after she
treated my gall bladder, I could move my neck. That's because holistics know how
one body part can "refer" pain to a seemingly unrelated body part. Conventional
doctors don't know that one body part has anything to do with another. If they
did, they wouldn't operate on the wrist for carpal tunnel syndrome when
the pain and tingling in the forearm usually stems from a pinched nerve in the
neck or back.
But mention to a physician that you see a holistic practitioner and he may
well call such party a "quack." That was the response of my primary care
physician after he discovered I'd been seeing a holistic chiropractor for
chronic back trouble. Sounding a bit like a spurned lover, he whined, "You
didn't have me look at your back."
But why see an MD for a misaligned back? So he can say, "It's not fractured. Do
you want a painkiller?" Indeed, to be a doctor in America all you need to know
is the word "painkiller."
"We're basically pill pushers," one young physician admitted at a party, adding
that, much like a diner waitress hoping you'll stick to the menu, doctors are
looking for the path of least resistance.
Unless you demonstrate classic symptoms of one of the six or so conditions that
fall into a medical doctor's limited repertoire of common, recognizable
conditions, he won't really know what's wrong with you until the autopsy. You
get more answers from a veterinarian, for crying out loud. (Which would explain
the expression "healthy as a horse.") From the physicals to the check-ups to the
trial-and-error means of diagnosing, coming into a doctor's office for any
reason other than antibiotics is an exercise in futility. It's a running joke
that a primary care physician's competence is best measured by how expeditiously
his staff fills out referrals.
God bless Western medicine for all the breakthroughs--the vaccinations, the
transplants, the emergency life-saving procedures and cutting-edge modern
miracles. But these days its practitioners perform best for those on the brink
of death, and that's where you'd better be when you come to these people, or
they'll bring you there.
I'm not saying doctors have to be flawless. I'm just asking them to appreciate
the difference between a patient and a piece of furniture. Because there are
errors, but there is also apathetic negligence, not to mention an arrogance that
is buttressed by a rigid hierarchy at hospitals, wherein ranking doctors can't
be questioned or corrected by nurses or lower doctors. It's not uncommon for
nurses to sneak around doctors' orders to keep from killing the patients, as a
nurse I knew observed another nurse do when the doctor was overdosing a patient
on intravenous medication.
Doctors must stop discouraging patients from seeking alternative care--whose
purpose is not to compete with, but to supplement, traditional care. Thankfully,
there are the "radicals" of the profession bridging the Western model and the
Eastern model, some practicing both, others referring patients to alternative
care specialists (which insurance companies are increasingly covering). There is
a place for both conventional and alternative medicine, and MDs should know
If any of the symptoms mentioned here hit too close to home for some doctors,
they should read this twice and call each other in the morning. And if the truth
still hurts, take a painkiller and ignore the problem.
Julia Gorin is the author of the newly released "The Buddy Chronicles,"
available through Bruiserbooks.com, and a contributing editor to
JewishWorldReview.com. She is the featured comedian in Republican Riot, a
monthly comedy show in New York.
'Major measles epidemics likely' due to MMR rates
The UK will face serious outbreaks of measles this winter unless parents stop
boycotting MMR, latest figures suggest. One of the doctors who first suggested
the triple jab may be linked to autism is now warning of 'major measles
epidemics'. This comes as the Health Protection Agency says there have already
been 360 confirmed cases of measles in the UK this year - compared with 308 for
the whole of 2002. And recent Welsh figures reveal 323 mumps cases and 40 cases
Latest Scottish figures also suggest a rise in childhood diseases over the past
18 months. Suspected cases of measles, mumps and rubella have risen by 18 per
cent, 27 per cent and 22 per cent, respectively. The HPA says national uptake
for MMR now stands at 78.7 per cent, although in parts of Wales, coverage is as
low as 69 per cent, and in parts of London it has dipped to 61 per cent.
In this week's Lancet, Dr Simon Murch of London's Royal Free Hospital, one of
the authors of the report that first sparked speculation of a link between the
MMR vaccine and autism, says low vaccine uptake means measles is 'certain' to
become endemic in the UK again, and the near elimination of congenital rubella
syndrome is likely to be reversed. 'Unless vaccine uptake improves rapidly,
major measles epidemics are likely in the UK this winter,' he says.
Dr Murch, who worked with Dr Andrew Wakefield on his controversial study, now
says there is 'unequivocal evidence' MMR is not linked to autism. RCGP spokesman
on immunisation Dr George Kassianos said unless the jab rate was 95 per cent,
there would be measles outbreaks. 'It's not whether you could - you will. In
some areas, it's so low that it's inevitable.' He added MMR was the saf- est
vaccine available for measles, mumps and rubella and single jabs had no place in
the UK's immunisation strategy.
Medical defence warning
Defence organisations have advised GPs to tighten up vaccination procedures
following accusations doctors have been giving MMR by stealth. The national
media has highlighted claims that children getting Haemophilus influenzae b
boosters have, at the same time, been given the triple jab without their
The accusation comes from Sarah Dean, chief executive officer of Direct Health
2000, which offers single vaccines. She said at least 70 parents had contacted
her company with such claims. Medical indemnifiers said they had seen no
evidence that GPs had been purposely giving MMR without parental consent and
that the threat of legal action would make it unlikely. However, they said
mistakes could occur with all jabs and advised GPs to make sure they got the
correct authority from parents.
Dr Stephanie Bown, of the Medical Protection Society, said: 'What's important is
that all practices have got a policy in place which makes sure that issues of
consent are clear.' Hertfordshire GP Dr Mike Ingram said that giving
vaccinations by stealth would be in breach of the 'moral code that binds general
Lancet, 2003, 362, 1498-9
Injuries in Hospitals Pose a Significant Threat to Patients and a Substantial
increase in Health Care Costs
Press Release Date: October 7, 2003
Medical injuries during hospitalization resulted in longer hospital stays,
higher costs, and a higher number of deaths in 2000, according to a study from
the Agency for Healthcare Research and Quality. The study, "Excess Length of
Stay, Charges, and Mortality Attributable to Medical Injuries During
Hospitalization," is published in the October 8 Journal of the American Medical
Researchers, led by AHRQ's Chunliu Zhan, M.D., Ph.D., found that the impact of
medical injuries varies substantially. Postoperative bloodstream infections had
the most serious consequences, resulting in hospital stays of almost 11 days
longer than normal, added costs of $57,727, and an increased risk of death after
surgery of 21.9 percent. Based on this data, researchers estimate that 3,000
Americans die each year from postoperative bloodstream infections. The next most
serious event was postoperative re-opening of a surgical incision, with 9.4
excess days, $40,323 in added costs, and a 9.6 percent increase in the risk of
death. This equates to an estimated 405 deaths from reopening of surgical
incisions annually. Birth and obstetric trauma, in contrast, resulted in
little or no excess length of stay, cost, or increase in the risk of death.
"This study gives us the first direct evidence that medical injuries pose a
real threat to the American public and increase the costs of health care," said
AHRQ Director Carolyn M. Clancy, M.D. "The nation's hospitals can use this
information to enhance the efforts they already are taking to reduce medical
errors and improve patient safety." The study used AHRQ's
Patient Safety Indicators and Healthcare Cost and Utilization Project's
National Inpatient Sample data to identify medical injures in
7.45 million hospital discharges from 994 acute care hospitals across 28 states
in 2000. The study provides, for the first time, specific estimates for excess
length of stay, charges, and the risk of death for each of 18 of the 20 AHRQ
Patient Safety Indicators.
"The message here is that medical injuries can have a devastating impact on the
health care system," said Dr. Zhan. "We need more research to identify why these
injuries occur and find ways to prevent them from happening."
For more information, please contact AHRQ Public Affairs: Ron Rabbu (301)
Karen Migdail, (301) 427-1855 (KMigdail@ahrq.gov).
Injuries in Hospitals Pose a Significant Threat to Patients and a Substantial
increase in Health Care Costs. Press Release, October 7, 2003. Agency for
Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/press/pr2003/injurypr.htm
July 26, 2002
2,610 Infants died of
preventable hospital-acquired infections - Chicago Tribune
President Bush would limit
health care liability
Clearly neither he nor
his advisers have considered The Chicago Tribune's investigative series,
Unhealthy Hospitals (excerpt below).
series should be required reading for members of the various research
"protection" advisory committees that are reinterpreting federal
regulations to accommodate the needs of the biomedical research industry.
Efforts are under way to give medical researchers easier access
to children who are being recruited--often against their best
interest--for painful research studies that bring them in contact with
hospital-acquired infections. These advisory panels have largely ignore
the existing lethal hazards that hospitals pose for children.
Instead, they lend support for unjustifiable experiments on the
theory that healthy children may be "at risk" of possible future illness.
investigation linked the deaths of 2,610 infants in the year 2000 to
preventable hospital-acquired infections--most were caused by
Hospital staff--doctors, nurses, and maintenance workers-- who failure to
follow simple hygienic procedures unsanitary: “The lack of hand-washing is
responsible for most germs spread in pediatric intensive care units, said
Dr. William Jarvis, chief of the CDC's hospital infections program.”
identified 75, 000 preventable deaths "where hospital-acquired infections
played a major role. This analysis, based on the most recent national
data, is the most comprehensive of its kind and draws on thousands of
hospital and government inspection reports."
Lax procedures put infants at
Simple actions by hospital
workers, such as diligent hand-washing, could cut the number of fatal
Second of three parts.
By Michael J. Berens Tribune
July 22, 2002
arrived two months early, weighing less than 3 pounds. For the first three
days, her life was charted from precarious to uncertain to probable. By
the fifth, she opened brown eyes and was weaned from feeding tube to
mother's milk. On the seventh, she died.
One of the
nation's most prolific and lethal germs, pseudomonas aeruginosa, was on
the loose in a hospital nursery.
parents say no one at Sinai-Grace Hospital in Detroit even mentioned the
infection to them. If it was a secret, it became one that was impossible
months in spring 1997, on the same floor, within the same nursery unit,
along the same row of bassinets, hospital germs contributed to the deaths
of three other babies and slipped undetected into 15 more newborns at
Sinai-Grace…..cut… In the majority of cases in pediatric intensive care
units, those lives might have been saved by simple acts of washing hands
or isolating patients the moment infections were detected, according to
inspection and investigative files at the U.S. Department of Health and
reveal hundreds of examples of unsanitary conditions and unsafe practices:
dripping from a common cold, a doctor in a Los Angeles hospital in 1999
worked the bedsides of newborn patients for half an hour without stopping
to wash his hands. Within a week, 12 critically ill children contracted
infections from pneumonia-causing staphylococcus germs. Two newborns died.
A hospital investigator traced the germ back to the doctor.
protection from a mask, gloves or gown, a New York nurse took the blood
pressure of a child suffering from staphylococcus, a germ that attacks the
respiratory system. She then immediately embarked on bedside checks in
another ward of at least six other premature infants, three of whom
contracted pneumonia and died in 1998.
investigators determined the nurse was the only common link among the
infected children [cut].
the infection problems inside pediatric units, the Tribune examined
computerized patient admission and billing records as well as state and
federal health-care enforcement records encompassing nearly 4 million U.S.
births each year.
among the most vulnerable patients, but they routinely are treated in ways
deemed inappropriate for adults within the nation's 5,810 registered
hospitals. Hospital investigations and CDC and Health and Human Services
riddled with infections often are treated side by side with healthier
babies in large intensive care units, allowing germs to spread among
patients. At least 1,200 hospitals use large pediatric wards as a
cost-effective way to treat the most children. But pneumonia-causing
germs, for instance, can become airborne from coughing and sneezing.
adult patients are usually segregated into different recovery rooms based
on malady, and they are usually cordoned off with curtains or other
barriers not typically found in pediatric wards. Adults also are more
likely to be isolated in private rooms, the CDC found.
nurses rapidly shuttling between the beds of infected patients and other
areas of the hospital unwittingly transported germs that are believed to
have led to deadly infections in at least 500 children in 2000.
Carelessness by nurses and aides also causes life-threatening injuries to
thousands more each year. Adult patients with infections are more commonly
treated by teams of nurses prohibited from contact with other patients.
estimated 200 newborns die each year because most hospitals are unwilling
to pay about $5 extra per catheter to use germ-resistant, silver alloy
catheters, a federal study found. Most ill babies are connected to
catheters, which are hollow, flexible tubes inserted into the body to
allow passage of fluids. Although the CDC and leading health-care agencies
have called for nationwide adoption of the germ-fighting catheters, many
hospital officials argue that the expense is not justified compared with
the number of infections prevented.
low-weight newborns are the most vulnerable patients to infection. Their
underdeveloped or non-existent immune systems often coincide with serious
cardiac and respiratory ailments.
can sneak up at you at times," said Mary Gould, infection-control
supervisor for Children's Hospital in Birmingham, Ala. "You can't be
looking at all directions at the same time.... Something could be going on
behind you [cut]...
particularly important in pediatric intensive care units, where
hospital-acquired infection rates range as high as 20 percent, compared
with less than 1 percent among infants born without medical complications,
according to the American Association of Critical-Care Nurses.
rates in pediatric ICUs rank higher than any hospital department because
nearly all patients are attached to respirators, intravenous pumps or
other invasive devices that can become an entry point for germs.
in the nursery
Hospital towers over Detroit's northwest side. Each year the 500-bed
medical center handles 3,700 births, about 10 new lives every day.
death of Tamia Jones on March 21, 1997, gave no pause to the pace.
On the sixth
day of Tamia's life, a laboratory test showed she had been infected by a
pseudomonas germ. But the infection caused by the germ worked faster than
the antibiotic that was dripped into her body through an intravenous line,
hospital records obtained by the Tribune show. She died the next day.
It took more
deaths of premature babies and nearly two months before the hospital
decided to close the nursery, segregate infected patients and scrub down
every piece of equipment.
is a water-based germ that can flourish in sinks, ice machines, damp
towels, on the leaves of potted plants, even inside hand-lotion
containers. The germ is typically spread by touch and can result in lethal
infections, including in the respiratory and urinary systems. Unlike some
germs that live on the skin, pseudomonas quickly looks for pathways into
the body, such as respirator tubes.
Infectious-disease experts said even one case of pseudomonas in a
pediatric intensive care unit should prompt immediate cleaning, isolation
and enhanced testing of all current and future patients in the ward.
Hafeez, chief of Sinai-Grace's infectious diseases department, who was a
lead investigator on the outbreak, defended the hospital's reaction,
saying the bacteria moved so quickly the children were infected before the
hospital could identify an outbreak.
think you could find anything that we could have done better," Hafeez
said. The hospital reacted quickly once the outbreak was identified, he
"I get upset
when someone says we should have been able to forecast that four children
were going to die," Hafeez said. "I got my degree in medicine. Not
astrology or palmistry."
characterized the deaths as the "price of modern medicine." Fragile
newborns lost 15 years ago are being kept alive with sophisticated
machines and stronger medicines, which make patients more prone to
"unbelievably virulent" germs like pseudomonas, he said.
banded together to file a lawsuit, hospital officials pointed the finger
of blame at Tamia's mother, Tracey Jones, who suffered several prenatal
complications the officials said could have been caused by a pseudomonas
germ. When Jones was brought to the hospital for an emergency Caesarean
section, she might have carried the germ into the facility, a pediatric
doctor at Sinai-Grace testified in a deposition.
There was one
problem with that theory. Doctors had taken swab tests of Jones' nose and
mouth in search of proof that pseudomonas lived on her body after Tamia's
death; the tests were negative, according to hospital records obtained by
confirmed the negative test results.
hospital never divulged to parents is that the germ was found on an
employee, internal hospital records show.
acknowledged for the first time to the Tribune that pseudomonas was found
on the hands of a respiratory therapist who had worked in the intensive
care unit. The therapist, he said, was ill and had undergone a colostomy;
a small tube ran from the therapist's abdomen, emptying body waste into a
areas of tubing or even the bag could have been breeding spots for the
germ, he said.
to the strain of pseudomonas found on the therapist's hands, hospital
tests identified two other strains in the intensive care unit, but the
source of those germs was never determined, Hafeez said.
Walsh, an attorney who represented the families of the dead children, said
the parents were never warned of the outbreak or that hospital officials
had identified the germ on any of their employees.
later testify in depositions that lapses in health care were all too
evident: Many nurses and doctors did not wash hands or wear gloves while
moving from crib to crib.
On March 30,
nine days after Tamia died, another baby girl was brought into the
neonatal unit. Alexis Crooms, weighing 1 pound 12.3 ounces, showed steady
improvement. She stopped breathing 19 days later. An autopsy revealed the
presence of pseudomonas.
laboratory evidence that Tamia had died from pseudomonas, Alexis was never
specifically tested for the germ while she was alive, according to court
depositions by doctors.
was in the nursery, a premature infant boy arrived and was placed in the
same row of bassinets. Within 17 days, Prateep Bazel Jr. was dead. Tests
done shortly before his death revealed pseudomonas, hospital records show.
can cause dozens of different infections, making diagnosis difficult.
Tamia developed inflammation of the spinal cord and brain; Alexis was
gripped by lung-destroying pneumonia; Prateep was overwhelmed by
inflammation of his internal organs.
baby died on June 26. Once again doctors identified pseudomonas, but they
were too late to save Breanna Friday, whose intestines were attacked by an
filed by the parents of the four infants was settled out of court in 1999
for an undisclosed sum. [cut]
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Posted on Sun, Nov. 30, 2003
Hospitals kept quiet on cause of infant deaths
By Toni Heinzl
Star-Telegram Staff Writer
SPECIAL TO THE STAR-TELEGRAM/JUDY LOWREY
Jacque Gibson White looks through photos of her only child, Rachel, whose death
was attributed to a treatment for premature babies.
SPECIAL TO THE STAR-TELEGRAM/JESSICA KOURKOUNIS
Alice Hernandez holds a stuffed toy that had belonged to her son, Jose, who
lived only four months. The hardest days for her are his birthday and Christmas,
when she visits his grave.
Fort Worth attorney Dwain Dent, who has represented 21 families in E-Ferol
lawsuits, believes the number of E-Ferol deaths is higher than the Food and Drug
Administration has reported.
Joe and Alice Hernandez look over Jose "Little Joe" Hernandez at Harris
Methodist Fort Worth in this 1984 photo. The autopsy said he died because of
Jacque Gibson White holds her daughter, Rachel, who was born in 1984 at Cook
Children's Medical Center and lived for 27 days. More than a decade passed
before White learned what caused Rachel's death.
Rachel Ann Eskew was born prematurely and was given E-Ferol to help prevent
blindness. She was among dozens of babies nationwide to die after being given
the intravenous vitamin E treatment.
Jose Hernandez III was born Feb. 18, 1984, and died four months later. His
mother, Alice, says she blamed herself for years until learning that her baby
had received an unapproved drug.
The Food and Drug Administration has blamed 38 infant deaths on E-Ferol Aqueous
Solution, which was recalled in 1984.
FORT WORTH - All Jacque Gibson White has left of her daughter, Rachel, are
memories, painful memories of stroking her baby's head and holding her tiny
hands every day of the four short weeks she lived at the intensive care nursery
at Cook Children's Medical Center.
Rachel Eskew was her only child.
Born prematurely, she had difficulty breathing. But Rachel was a fighter. White
noted in her diary a ray of hope: On Feb. 25, 1984, three days after she was
born, Rachel's doctors pegged her survival chances at 85 percent.
Then Rachel suddenly took a turn for the worse. She died March 20, 1984. Doctors
initially told White that the cause of death was kidney and heart failure for
Two years later, the hospital learned that Rachel was among dozens of premature
babies nationwide who died after being given E-Ferol Aqueous Solution, an
intravenous vitamin E preparation intended to help prevent blindness. But the
hospital didn't notify White of the finding. In fact, it would be 11 more years
before she learned why her daughter died.
Many other hospitals, perhaps fearing costly lawsuits, also kept families in the
dark about the potential link between the deaths or disabilities of their babies
and the administration of E-Ferol, which had been marketed without the approval
of the Food and Drug Administration.
Now, a federal lawsuit is aiming to force hospitals to disclose the link. At
issue is whether hospitals must contact former patients or their families after
it is discovered that some aspect of their care may have harmed them.
Cook Children's stance is that notification by the hospital violates
doctor-patient confidentiality. Other hospitals have adopted policies to notify
patients or families if hospital doctors ascertain that medical or
pharmaceutical errors led to serious injury or death, policies that White's
attorney maintains should be required of all hospitals.
In the E-Ferol cases, the disclosure issue has taken on urgency because time is
running out for parents and patients who survived to sue the corporations that
manufactured and sold E-Ferol and the hospitals that administered it.
The statute of limitations in state courts expires 20 years after the babies
suffered illness or died. The drug was recalled on April 11, 1984, as death
reports mounted from hospitals across the country.
The E-Ferol tragedy resulted in criminal prosecutions of corporate executives.
Three executives at two companies that manufactured and sold the drug were
convicted of fraud, misbranding and selling an unapproved dangerous drug; they
were sentenced to six months in federal prison.
Outrage over the deaths prompted congressional hearings that exposed weaknesses
in the nation's regulatory system for pharmaceutical drugs.
But it was never fully ascertained how many deaths or injuries to premature
babies the drug caused.
FDA reports indicated that the drug was administered to more than 1,000 babies
at more than 100 hospitals, including Cook Children's, Harris Methodist Fort
Worth and Baylor Medical Center of Dallas. Based on information provided by
hospitals, the FDA reported that at least 38 babies died out of about 100 who
suffered such adverse reactions as blindness or damage to the kidneys, liver or
There were no autopsies in some deaths because doctors blamed the babies'
prematurity and related ailments, such as underdeveloped lungs. That's the
position taken by some hospitals that resist disclosing the names of babies who
were given E-Ferol. Cook Children's spokeswoman Carolyn Bobo would not comment
on any individual case, instead offering a statement:
"In 1984, neonatologists at Cook Children's cared for several infants whose
families were later involved in litigation related to use of E-Ferol, a drug
used to treat babies born with extreme prematurity. Neonatologists followed
standard care guidelines for these infants. The FDA notified physicians and
hospitals throughout the United States that E-Ferol should be withdrawn from
use. Neonatologists at Cook Children's stopped use of the drug immediately.
"Physician testimony clearly indicates that these infants suffered from extreme
prematurity and complications related to extreme prematurity, and that use of E-Ferol
was not a significant factor in their care, health or survival at Cook
Seeking the victims
One of the experts who exposed the dangers of E-Ferol was Dr. Robert Brown, a
pediatric pathologist at Cook Children's.
Brown had studied E-Ferol syndrome in 1984 and 1985 with partial funding from
the hospital and published his findings about the drug's harmful effects in an
April 1986 article in Pediatrics, the journal published by the American Academy
After Rachel's death, her doctors asked Brown to perform an autopsy
consultation, in which the initial autopsy is scrutinized. In his report, dated
Dec. 15, 1986, he concluded that Rachel died of E-Ferol syndrome. Brown wrote to
one of Rachel's physicians that he would be willing to meet with Rachel's
doctors and her parents "to discuss these new findings."
Brown also notified the hospital's administration. But no one told White. Nor
did the hospital notify others whose infants received E-Ferol. That became a
central issue in a long-running liability lawsuit in state district court in
Tarrant County. The company that manufactured E-Ferol, Carter-Glogau
Laboratories of Glendale, Ariz., and the drug's distributor, O'Neal, Jones &
Feldman Pharmaceuticals of Maryland Heights, Mo. -- have been willing to offer
settlements in cases where it can be proved that infants received large enough
doses of E-Ferol to cause health problems or death, said Dallas lawyer David
Taylor, who represented the corporations in about 20 E-Ferol cases in North
The companies, which went out of business after the scandal but still exist in
little more than name only to resolve lawsuits in about 20 states, have settled
about 130 E-Ferol lawsuits nationwide. The settlements include cases involving
the deaths of six infants in Tarrant County.
Not a single case has gone to trial. But the companies do not know which babies
received the drugs. They know only which hospitals received E-Ferol, information
O'Neal provided to the FDA during the recall. "My client [O'Neal] sold the
product to the hospitals -- the FDA did not know which patients got the drug,"
Taylor said. "Only the hospitals knew. "In some cases, hospitals made
extraordinary efforts to reach families; in other cases they didn't. As today,
there was a lot of pressure on litigation, and some hospitals are afraid to get
sued." Cook Children's reported to the FDA that it had given the drug to
seven infants, according to an FDA document dated June 12, 1984. But attorney
Dwain Dent of Fort Worth, who has represented the families of 21 infants in
product liability lawsuits involving E-Ferol, believes the number of babies who
died or suffered health damage because of E-Ferol nationwide and in Tarrant
County is much higher than the official figure because the FDA relied on
potentially incomplete reports from the hospitals as the tragedy unfolded.
Dent asked the court to force disclosure of the names, and Cook Children's
resisted. Bobo, the hospital's spokeswoman, declined repeated requests for
interviews with hospital officials or attorneys and declined to answer questions
about infants who received E-Ferol. Court papers outline the hospital's key
position that revealing the information would violate doctor-patient privilege.
Former hospital President Peggy Troy testified in 1999 that it was a doctor's
responsibility to tell a patient if he or she has been injured or harmed or
given an illegal drug such as E-Ferol. In one exchange during the deposition,
Troy acknowledged that the hospital did not intend to volunteer the information
to the patients or their parents. Dent: "I'm asking if you, as the executive
officer of the hospital, have visited with any committees about notifying
parents of these children that they received this ... drug during 1984 in your
Dent: "And is it on any agenda for the future?"
Dent: "And do you intend to ever give them notice?"
In their rulings in favor of disclosure, two state courts rejected the
hospital's claim of doctor-patient privilege.
In an Oct. 18, 2002, order, District Judge Tom Lowe said he had to balance the
patients' right to privacy with their "right to know that they have been
administered an illegal, non-FDA approved and potentially harmful or lethal
drug." "Of concern to this court is that some child may be suffering
consequences of E-Ferol toxicity and may not know it," Lowe wrote.
After the 2nd Court of Appeals in Fort Worth upheld Lowe's conclusion, the
hospital asked the Texas Supreme Court to review the ruling. Dent then dropped
the case. He said he feared that it could be years before the Supreme Court took
up the case.
"The kids might lose their rights to file a complaint," he said.
Instead, Dent decided to seek class-action status through a lawsuit in federal
court in Wichita Falls. The suit was filed May 29 on behalf of two plaintiffs in
Texas and Georgia and all others who received E-Ferol as premature infants
between December 1983 and April 1984.
It has been scheduled for a four-week trial in November 2004 before Senior U.S.
District Judge Jerry Buchmeyer. "We continue to push for disclosure because we
think all families [have] got to know if their child got this dangerous drug in
1984," said Dent, who teamed with Fort Worth lawyer Art Brender in the federal
lawsuit. "I'm a parent of two. I'd want to know."
The hospital has sued O'Neal and Carter-Glogau in federal court to recoup more
than $250,000 in attorneys' fees and expenses it incurred in defending the
health-care liability action in state court. In federal court filings, the
hospital describes itself as a victim of the manufacturer and distributor. "Cook
was nothing more than an innocent seller of the drug-manufacturing defendants'
defective product," the hospital said.
Taylor acknowledged the mistakes the two companies made. But he said they are
not willing to pay for the hospital's refusal to turn over the patient names.
"Cook's was in this lawsuit because the plaintiffs wanted information from
Cook's, and Cook's refused to provide the patient records," Taylor said. "Our
position is that it is not our problem to defend Cook's for refusing to give out
information. We are defending the product."
The fee-dispute case is still pending before U.S. District Judge Terry Means in
Parents not informed
The death of Alice Hernandez's first child, Jose, overshadows her life to this
day. Jose Hernandez III, or "Little Joe" as his parents called him, was born at
Harris Methodist Fort Worth on Feb. 18, 1984. He died exactly four months later.
Hernandez, 43, of Mesquite, then a pharmacy technician at Harris Methodist H.E.B.,
went to see Little Joe at the hospital every day, often staying until late at
"When he started getting worse, we asked the head of the ICU if they could give
us a different doctor or do anything else," Hernandez said. "They said no, there
was nothing else they could do. "The autopsy said he died from underdeveloped
lungs. He was fine the first week he was born. He weighed 2 pounds, 9 ounces at
birth and was 15 1/2 inches. When he died, he was 9 pounds and his entire body
was swollen. He went downhill after he got the drug."
Hernandez wishes the hospital had voluntarily told the families about the E-Ferol
treatment immediately after it was recalled. She found out that her son had
received high doses of the drug only after hearing from another mother whose
premature baby girl had died at Harris that spring.
Hernandez reached a confidential settlement with O'Neal and Carter-Glogau in
1997. Though Harris didn't notify parents or patients at the time of the recall,
it has taken a different stance from Cook Children's. Harris, also named as a
co-defendant in Dent's previous state lawsuit, complied with requests to produce
the names and then was released from the lawsuit. Dent still has one new state
case pending against Harris. A spokeswoman for Harris, Laura Van Hoosier,
declined to comment.
Harris gave Dent the names of 41 of the 80 patients who hospital officials told
the FDA had received E-Ferol, saying those were all the names it could retrieve
and that some patient records may have been lost, Dent said. That stance is more
in line with recommendations from physician associations, pharmacist groups and
consumer advocates, who say that health-care providers should promptly inform
patients of serious medical errors.
"Once an organization has determined that a patient was given a dangerous
substance or an error has occurred, the institution has a duty to notify
patients or their families," said pharmacist Casey Thompson, an expert on
patient safety issues with the American Society of Health-System Pharmacists.
"Ethically, it would be the right thing to do."
That's not only in the patient's best interest. An often-cited 1999 study of a
disclosure policy at the Veterans Affairs Medical Center in Lexington, Ky.,
found that openly acknowledging serious errors and taking swift measures to
prevent similar mistakes actually helps reduce the number of malpractice
lawsuits and the amount of damages awarded.
For Hernandez and White, the delay in notification added to their grief.
"The mothers carry this guilt for such a long time," Hernandez said. "I blamed
myself and God for 10 years, until I found out the truth." The hardest days for
Hernandez are Little Joe's birthday and Christmas, when she makes the trip to
Fort Worth's Mount Olivet Cemetery to visit his grave. White did not learn about
Brown's finding on her daughter's death until November 1997, after her
ex-husband, Brinkley Eskew, responded to an advertisement by Dent's law firm
seeking witnesses who had babies at Cook Children's during the time E-Ferol was
At Eskew's request, the hospital released his daughter's records -- without any
explanation of what the medical files meant and without acknowledging that she
was killed by E-Ferol, Dent said. Dent later wrote to White to tell her of
Brown's findings. White then sued the two companies in state district court and
reached a confidential settlement this year, as had Eskew. Dent dropped White's
state liability suit against the hospital before turning to the federal courts.
White, who now lives near Newport News, Va., insists that doctors and hospitals
should notify parents when mistakes are made that cause serious health damage or
death. "I spent all these years since she died blaming myself, believing that it
was completely my fault that I don't have my child," White, 43, said. "I would
not have had to live with that guilt so long had I known." During the 27 days of
Rachel's life, White wrote in her diary every day. Occasionally, she flips
through the pages, taking a journey into a distant, never-ending past.
Tale of trouble with E-Ferol
Here is a timeline of the drug E-Ferol, which was manufactured by Carter-Glogau
Laboratories of Glendale, Ariz., and distributed by O'Neal, Jones & Feldman
Pharmaceuticals of Maryland Heights, Mo. August 1982: O'Neal executive James
Madison writes to Carter-Glogau President Ronald Carter inquiring about the
feasibility of a water-soluble vitamin E preparation for IV infusion. Madison
suggests using deception to get the product to the marketplace before a
November 1983: O'Neal introduces E-Ferol, and sales exceed expectations. O'Neal
sells 25,800 vials in the first five months. December 1983: A doctor in Hawaii
tells Madison that two babies became ill after receiving E-Ferol. January 1984:
A doctor in Spokane, Wash., tells Madison that three babies have died and
another is gravely ill. Madison replies that E-Ferol has been proved safe and
threatens the doctor with a lawsuit if he goes public with his suspicions.
March 1984: The Centers for Disease Control and Prevention receives reports from
hospitals in Cincinnati and Knoxville, Tenn., about unusual illness in 13
premature babies with low birth weights. Eight infants who received E-Ferol
died. April 1984: The CDC contacts the Food and Drug Administration, and O'Neal
and Carter-Glogau agree to recall E-Ferol.
July 1987: A federal grand jury returns a 25-count indictment charging Madison,
Carter, O'Neal President Larry Hiland and the corporations with conspiracy to
commit mail and wire fraud and with violations of the Federal Food, Drug and
Cosmetic Act. 1988: Carter, Hiland and Carter-Glogau are convicted. Madison and
O'Neal plead guilty to reduced charges. January 1989: Carter and Hiland are each
sentenced to six months in jail and fined $130,000 each. Madison is sentenced to
six months in jail and fined $12,000. The two companies are fined a total of
$260,000 and ordered to pay $215,000 for the cost of the government
Toni Heinzl, (817) 390-7684 email@example.com
HOSPITALS: Are we sure they're places where people go to get
Hospitals are dangerous places, as new research has confirmed. Well over 30,000
patients die in American hospitals every year from some medical mishap, while
167,000 will suffer a serious injury that will at the very least extend their
hospital stay. And the bad news-if that was not bad enough-is that the picture
is far worse than the one presented, researchers who produced the study have
The most dangerous procedure was vaginal delivery by forceps and other surgical
instruments, with over 22 per cent of all procedures resulting in injury. The
second highest was caused by vaginal birth without forceps, with nearly 9 per
cent of all procedures injuring the patient. But postoperative sepsis-which
occurs in 1.12 per cent of all patients-had the biggest impact, resulting in an
extended hospital stay of an additional 11 days.
This alarming picture, prepared by researchers from the Johns Hopkins University
in Baltimore, is a 'best guesstimate' based on 7.45 million discharge records
collected from 994 hospitals across 28 states in the USA during 2000. As the
researchers say, nobody knows the true picture, and their own evaluation is a
very conservative one compared with previous research studies, including one
that estimated that medical mistakes cause 98,000 deaths a year in American
The researchers concede that the situation is far worse than the one they have
reported-but just how worse is anyone's guess.
(Source: Journal of the American Medical Association, 2003; 290: 1868-74).
BELLEVUE -- A man with no medical license who gave $45 flu shots here is under
investigation by the state Department of Health and the Bellevue Police
Department, officials said Tuesday. Officials and at least one parent are
wondering if the shots actually contained vaccine.
Shahid Sheikh gave flu shots in an office space at 1611 116th Ave. N.E., but on
Tuesday the doors were locked and phone disconnected. ``He´s not licensed as a
doctor, nurse or medical assistant,´´ state Department of Health spokesman Donn
Moyer said. ``This person is a registered counselor and that category of
provider has no authority to give injections.´´ Moyer said the department has
opened an investigation into Sheikh, a registered counselor since June, and
asking questions of Dr. Clarence Niles, a registered doctor and surgeon since
1984 who might be affiliated with Sheikh.
.. and another thing
We may have finally found a drug company representative we can trust.
Earlier this month, a BBC News report quoted Allen Roses (a senior executive of
Europe's largest drug maker, GlaxoSmithKline) as saying that more than 90
percent of all drugs are effective for only 30 to 50 percent of those who use
I had to read that twice to make sure my eyes weren't deceiving me.
That comment is something you might expect to hear from a dedicated herbalist or
some other alternative healthcare practitioner. But you don't expect to hear it
from a high-placed honcho for an international drug giant.
Why would Mr. Roses utter such a statement? Apparently because he's a genetics
expert with an eye toward the future of pharmaceuticals in which drugs will be
tailored for specific genetic types.
It seems, however, that other executives at GSK may not have been delighted by
the press coverage of Mr. Roses' comment. The following day, the UK's Daily Mail
reported that GSK was "on the warpath" over the way the comment had been
portrayed as a "gaffe."
A GSK spokesman told the Daily Mail that Mr. Roses' statement had been
misrepresented. The unnamed spokesman said that anyone working in healthcare
knows that "most people respond differently to medicines." And, "Although
medicines may not work in all patients, they do work in a very large
So the spokesman basically rephrased Mr. Roses' comment to make it more
ambiguous, without actually refuting the truth of it. That's what you call
closing the barn door after the cows are out.
But we already knew the truth about those "cows."
To Your Good Health,
Health Sciences Institute
U.S. IMMUNIZATION NEWS
"State Evades Flu Shot Scam"
Atlanta Journal-Constitution (www.accessatlanta.com/ajc) (12/25/03) P. 1A;
Georgia paid $1.65 million to purchase 100,000 doses of the flu vaccine from a
Texas company but was later informed by the FBI that the company does not
possess the product. After checking out the Texas company's license to sell
prescription drugs in the United States, Georgia health officials decided to
purchase the vaccines for a significantly higher rate, because the higher priced
flu vaccine was still cheaper than purchasing FluMist, the nasal spray flu
vaccine. The state is getting a refund of its entire payment in three payments,
two of which already arrived. Details of the investigation remain undisclosed;
however, similar fraudulent cases are pending concerning the flu vaccine in
Unfortunately, the common myth that vaccines are
harmless, that doctors are infallible and that medical researchers are
seldom unethical contributed to the blind trust that caused this tragedy.
The "sacred cow" status of vaccines must be replaced with a more realistic
understanding that every experimental or licensed vaccine, like every
experimental or licensed drug, can carry significant risks for
individuals. The right to informed consent to taking a risk with a medical
intervention, such as vaccination, should be considered a human right
because each human being has the moral right to voluntarily choose what
they are willing to die for.
Patients: Oklahomans used as human 'guinea pigs'
A cancer research project may have used Oklahomans as
human guinea pigs.
In late 1996 a Tulsa doctor concocted a vaccine
designed to fight deadly skin cancer. Sources close to the doctor say he
believed in his research. He tested it on about 100 people, mostly
Oklahomans, some of whom now believe that research nearly killed them.
Five years ago, Jeff Teel was diagnosed with deadly
skin cancer. Doctors gave him a 20 percent chance of survival. "I mean, I
was petrified," he said, "thinking I was going to die." Surgeons removed a
portion of Jeff's arm, but the likelihood of a cancer comeback was high
and Jeff thought his best chance was an investigational new drug.
A public service announcement aired on local TV in
Tulsa and starred Dr. Michael McGee, principal investigator for the
melanoma cancer project at OU Health Sciences-Tulsa. McGee believes his
research could help cure melanoma cancer.
"They're told that this is a vaccine designed with a
purpose to fight tumors and keep tumors from coming back once they've been
removed," said Attorney Robert Seacat, who is representing some of McGee's
patients in a lawsuit. In 1998 Teel signed up for McGee's melanoma study.
According to the consent form, Saint John Medical Center and OU Health
Sciences are working together. McGee had an office in the basement of
Saint John's, the factory for his experimental vaccine.
"He said he had a very high success rate," Teel said.
"That there were minimal side effects. I was hooked right there." But,
Jeff and Paige Teel soon realized minimal side-effects meant something
very different. "It was like the worst flu you've ever had in your life
times 10 and it was guaranteed," he said.
"It was like he was being poisoned," Paige said. "Like
his body was fighting the poison in his system." Despite being violently
ill, Jeff endured the poison. At first, the treatments were weekly, then
monthly for two years.
"He told me because of my illness, my body was fighting
it off. That's what was supposed to happen," Teel said. But while Jeff and
about 100 others continued on Dr. McGee's experimental injections, a
whistle-blower inside the melanoma project was reporting allegations of
faulty research to the federal government. Attorney Robert Seacat is
representing some of McGee's former patients in an ongoing lawsuit.
"The rats and the monkeys in cages in laboratories
have better, adhered to anyway, regulations and standards of care than
what we have in some research projects," he said. According to a Food and
Drug Administration inspection, a laundry-list of violations were found.
They included: failure to report side effects, failure to properly store
vaccine, failure to control how vaccine is administered.
"One of my clients, he [Dr. McGee] literally gave her
a box of the vaccine. Told her to go home and put it in the refrigerator.
So she could self-inject at home," Seacat said. Four years after it
started, the FDA closed the doors on doctor mc-gee's melanoma research.
Subsequent reports from the Office of Human Research Protection show the
violations extend beyond Dr. McGee all the way up to senior officials.
"It's a shorter conversation to talk about what they
did right than what they did wrong," Seacat said.
Now, patients such as Jeff, are finally learning the
real reason for Dr. McGee's research. Even though some of the researchers
believed the vaccine had the potential to ward of cancer, McGee's study
was not a test for the effectiveness of the melanoma vaccine.
"The reality is, his study was simply to study toxicity
levels," Seacat said. "To see whether it made you sick and how sick it
made you. These people all thought they were getting on a study that would
give them some hope for living. When, in reality, he was just using them
as human guinea pigs." Volunteers relying on a miracle were left wondering
if an Oklahoma researcher put their lives on the line. "He's a Dr.
Frankenstein, as far as I'm concerned," Paige Teel said. The University of
Oklahoma settled the lawsuit with the former patients and issued a
statement about their human testing programs. They say they've
completed all the corrective actions spelled out by the
Office of Human Research Protections and fired the board of administrators
supervising Dr. McGee. They now have mandatory certification for
education on the ethical principals for protecting
Lawyers for Dr. McGee said: "the safety of the study
participants was never compromised." They say an independent audit showed,
"no notable pattern of adverse experiences." They say "the vast majority
of the problems were administrative in nature, and could've been remedied
had the university provided adequate resources." Those lawyers also point
out, several patients sued to continue taking the experimental vaccine.
We're told they're still taking that vaccine, with FDA approval. As for
Dr. McGee's supervisors, their attorneys said they were used as scapegoats
to protect OU's reputation. Dr. McGee is still practicing. He's a general
surgeon operating in Tulsa. The FDA suspended him from further research.
PROSTATE CANCER: Hair today, and you're gone tomorrow
Finasteride is a drug hailed as the great new hope to combat prostate
cancer. And its standing won't have been dented by a major new study that
concluded that the drug can, indeed, prevent or at least slow the cancer.
The Prostate Cancer Prevention Trial is a heavyweight study that involved
18,882 men aged over 55 years, and so its findings will matter. Of course,
there was a price to pay by those men who took the drug. Their sexual
libido all but disappeared, but many might feel that it is a trade-off
worth making if you live longer.
And there was another thing mentioned in passing. Those who took the drug
also ran a far higher risk of getting a more virulent form of the cancer
later on. Since the study started, finasteride was also approved as a hair
growth drug for men with male-pattern baldness. So let's get this right.
Take finasteride and your hair might grow back. But your sex life
disappears, and you stand the chance of getting an aggressive form of
Does anyone need hair that badly?
(Source: New England Journal of Medicine, 2003; 349: 215:24).
Millions at risk from script errors
By Mary Papadakis
AUSTRALIAN doctors are making potentially deadly mistakes in more than 4½
million prescriptions each year. Almost one in 40 prescriptions contain
errors, ranging from simple administrative mistakes to dangerously
incorrect drug types and doses. Decimal points placed in the wrong spot,
illegible handwriting, adult drugs given to children and wrong
instructions are some of the mistakes putting lives at risk.
Australian Council for Safety and Quality in Health Care chief Bruce
Barraclough said more than 500,000 Australians required hospital treatment
each year because of prescription errors.
Professor Barraclough said problems stemmed from the wrong medicine or
dosage and the under-use, overuse or misuse of drugs. Medical and hospital
errors have been estimated to cost about $4 billion and claim up to 18,000
lives each year. Professor Barraclough said most errors were made by
GPs and specialists working in the community. "We would say that 2.4
per cent of about 190 million prescriptions made each year have some sort
of error," he said. "Some are picked up by the pharmacist or the
patient." Professor Barraclough said not all prescription errors had the
harm patients but any mistake was a concern. "Doctors need to be
very aware when they are working and ensure they are working safely," he
Patients also had to take greater responsibility, be honest about their
medical histories and query anything that did not make sense. Australian
Medical Association Victorian president Dr Sam Lees said measures were
being taken to reduce prescription errors. "A pressured doctor can
make mistakes, but since the advent of computer prescribing, that's
helping to reduce the risk," he said.
"There is also intense teaching on proper prescribing, particularly for
young doctors." Dr Lees said that while an error rate of 2.4 per
cent was "not alarming", the AMA was working on it. "We will
probably never get to zero per cent but we have to keep working towards it
as a golden goal."
Parents' anger over MMR threat to GPs
BY VICKI SHAW
PARENTS today reacted angrily to news that GPs will lose Government cash
if they fail to immunise children with the controversial MMR vaccine.
Doctors used to receive bonuses for achieving targets on vaccinating
children with the triple measles, mumps and rubella jab. But now, a new
policy set down by the Commission for Health Improvement (CHI), states
that GPs will LOSE money if they fail to convince enough parents to have
Today family support groups said the new ruling was "outrageous" and put
the doctors "between a rock and a hard place." Wakefield mum Maria
Woodward, who believes her daughter Francine, 12, was left epileptic and
with learning difficulties after having the jab, said: "It's just
ridiculous. "GPs would happily provide the separate vaccines parents have
been calling for, but the Government won't allow them. Why should they be
penalised for something that is not their fault. "Instead of
punishing people, the Department of Health should concentrate on restoring
the public's confidence in MMR by instigating a fully public inquiry. "I
am concerned that doctors will begin to put extra pressure on parents when
they are already making what is a terribly difficult decision."
Uptake rates for the combined jab have fallen to an all-time low, with
only six in ten children in some areas having the vaccine. Parents began
shunning the jab following a report by Dr Andrew Wakefield of the Royal
Free Hospital in London which linked the vaccine to bowel disorders and
autism. His findings have since been refuted by several other major
reports and his own colleagues who worked on the study in 1998 have
distanced themselves from him. Parents have been calling for the NHS to
provide separate vaccines which they believe put less pressure on the
However, the Department of Health insists the triple jab is safe and
refuses to provide single injections for free. The new CHI ruling will see
doctors given star ratings for the number of children they immunise. If
they are downgraded they could lose essential cash for their local Primary
Care Trust. In the past, NHS hospital trusts that fail to achieve the
maximum three stars have lost £1m a year each. It is not known how much
cash is attached to the GPs' new inoculation targets.
12 January 2004
Public Citizen Press Releases
Providing the latest information about Public Citizen activities
Feb. 26, 2004
Accutane Linked to Birth Defects, Should Be Pulled From Market,
Public Citizen Tells FDA
WASHINGTON, D.C. - The acne drug Accutane, which causes birth defects
and life-threatening adverse events, should be removed from the market
and prescribed only under very limited and controlled conditions,
Citizen told a government panel today.
At a meeting of a U.S. Food and Drug Administration (FDA) advisory
committee, Dr. Sidney Wolfe, director of Public Citizen's Health
Research Group, described how the drug causes such birth defects as
malformations of the heart and brain, and can cause depression and
create pressure in the brain in patients taking it. About 25 percent of
the babies born to mothers taking the drug have serious birth defects
and 50 percent are mentally disabled. Many women who become pregnant
while taking the drug have abortions because of this high birth defect
Accutane is approved only to treat severe cystic acne but is prescribed
to many people who have mild acne. In fact, it is prescribed to 26
more women than it should be, Wolfe estimates.
A program launched in April 2002 by the FDA and Accutane's
manufacturer, Roche, was designed to reduce the number of pregnant
taking the drug, but it has not worked, Wolfe said. In the program's
first year, 48 of 61 reported pregnancies (79 percent) ended in
abortions because of concerns about the high rate of birth defects
caused by the drug. Applied to the estimated number of total
in women taking Accutane during that year, an estimated 431 women had
abortions because of the drug's high defect rate, 16 infants were born
with birth defects and 31 babies were born with mental retardation.
1982 to 2000, 162 babies were reported born with birth defects
attributable to Accutane.
"If the government doesn't act, this administration and advisory
committee will continue to put its imprimatur on the reckless use of a
drug that each year causes the need for hundreds of abortions and
results in many seriously deformed infants with birth defects," Wolfe
said. "This is one of the two worst epidemics of preventable serious
birth defects ever seen in the United States. It is time to end it."
Officials have known for at least 20 years of the dangers associated
with the drug. In 1983, Public Citizen petitioned the FDA to give
patients warning information with the drug. In 1988, Public Citizen
petitioned for a ban on Accutane, but the agency didn't act. Public
Citizen will petition the agency again soon for the drug's withdrawal,
Wolfe said. Wolfe told officials today that the drug should be
prescribed only if photographic proof exists of severe cystic acne and
the patient has not responded to other acne treatments. In addition,
women, a written statement should detail the patient's contraceptive
practices and the patient should have a negative pregnancy test.
To see Wolfe's statement, go to
Medical error causes 40,000 deaths a year
Friday, 13 Aug 2004 10:40
New statistical analysis from the Dr Foster Unit has concluded that 40,000
people die a year following medical mistakes. Drawing on data from the
National Patient Safety Agency (NPSA) it concluded that there are around
850,000 "adverse incidents" in NHS hospitals each year. It suggests that this
may be an under-estimation of the real extent of the problem.
The Dr Foster Unit notes that the rate of reportage of adverse incidents in
trusts ranges from 0 per cent to 15 per cent, and says that it believes the
zero reportage rate to be "unlikely". It also cites previous studies which
suggested that routine data reports less incidences than analysis of case
notes and argues that "adverse events may be under-recorded within hospital
episode statistics." An adverse even is defined as "an unintended injury
caused by medical management rather than a disease process, resulting in
death, life threatening illness, disability at the time of discharge,
admission to hospital, or prolongation of hospital stay."
Looking at hospital statistics over the past four years, they conclude that
2.2 per cent of all hospital stays mention an adverse event. Mistakes were
more likely to occur in the cases of male patients, elderly people and
emergency admissions- though for these groups the report notes "the
differences may be due in part to the severity of underlying disease in the
different groups and the length of time people are in hospital." The
researchers conclude that incidences are being recorded, but "hospitals
should be encouraged to improve the recording of events on their systems."
The Dr Foster Unit is based at Imperial College London and is an independent
organisation "created to examine measures of clinical performance."
In national survey, 45% of specialists report a recent medical error
Otolaryngologist Dr. David Roberson has first-hand experience with
medical errors. He remembers one near-miss in a patient about to receive
a cochlear implant – and says it typifies the kinds of mistakes he and
his colleagues have turned up in a national survey.
"I looked at the CT scan carefully to determine if the cochlea would
accept the implant," recalls Roberson, from the Department of
Otolaryngology and Communication Disorders at Children's Hospital Boston.
"I asked a colleague to look at it also, and he commented that the
auditory nerves looked small. I then ordered an MRI which showed the
patient had no auditory nerves on either side. I came close to performing
surgery and putting a major device in a child's head when there was no
possibility of benefit, since she had no auditory nerve. I didn't look
carefully enough at the entire scan."
Roberson and colleagues sent a brief, anonymous survey to 2,500
members of the American Academy of Otolaryngology-Head and Neck Surgery,
and received 466 responses (19 percent). Of these, 210 physicians -- 45
percent -- reported that a medical error had occurred in their practice
in the past six months. Errors occurred in all phases of patient care; 78
(37 percent) caused major injury or harm, and 9 (4 percent) were fatal.
Both adults and children were affected.
Errors were carefully classified. The largest category, accounting for
19 percent, was technical errors during procedures, and 56 percent of
these caused major injury or harm. Next were medication errors (14
percent); these included dosage mistakes and giving medications to which
the patient was allergic, or that were contraindicated. Testing errors
(10 percent) included physician errors (ordering incorrect tests; not
reviewing tests; not acting on the results) and lab errors (lost
specimens; errors in labeling and interpretation of results). Surgical
planning errors (scheduling mistakes; failing to ensure that all
preoperative studies were complete; and judgment errors, such as
undertaking surgery when it was risky) accounted for another 10 percent.
Younger physicians were more likely than physicians over age 50 to
report errors (approximately 60 versus 40 percent).
Other errors included:
|Equipment errors – equipment not available or improperly assembled;
equipment failure (9.4 percent)|
|Errors in post-operative care (8.5 percent)|
|Wrong site surgery – wrong patient, wrong organ, or wrong side (6
|Drug errors during surgery (4 percent)|
|Communication errors (4 percent)|
Roberson and colleagues believe that the proportion of physicians
encountering an error -- 45 percent –- is an underestimate. They suggest
that doctors may not be trained to recognize errors, and may tend to
recall errors that have serious consequences but overlook minor ones.
In one of two editorials accompanying the study, Dr. Lucian Leape of
the Harvard School of Public Health concurs, "In the absence of a
significant adverse event, most clinicians do not recognize (or admit)
Leape adds that the study provides a unique and useful classification
scheme for medical errors. "Not only does this scheme make clinical
sense, it would seem to have applicability to other surgical
specialties," he writes.
The study is the cover article in the August issue of the journal
Laryngoscope. "The probability of an otolaryngologist erring on any
individual decision is miniscule," the authors note. "However, because we
all make millions of medical decisions, we will all make many errors
during our careers… Most errors are made by good or outstanding
Doctors lift lid on MMR scandal Aug 8 2004
By Caroline Wheeler, Sunday Mercury
Scores of children in the Midlands may have been given the controversial MMR
jab without their parents’ permission, a leading doctor claimed last night.
And nurses have been caught trying to administer the MMR jab alongside
children’s pre-school diptheria booster - even after being told not to by
The news comes just a month after three year-old Michael Whitfield, from
Kidsgrove, Staffordshire, was given the triple-jab without his parents’
permission. The toddler had the jab by mistake by a nurse at his GP’s surgery
- despite having already received separate injections at a private clinic.
Now a doctor, who asked not to be identified but who runs a clinic offering
the option of single vaccines, has lifted the lid on yet another MMR scandal.
“I have seen scores of parents who claim that nurses tried to give their
children the MMR vaccine without permission,” he said.
“It usually happens when the child has gone for their pre-school diphtheria,
pertussis and tetanus boosters. “Some of the more alert parents have
stopped their child from being given the the triple vaccine. “But for every
parent who notices what is going on, I wonder how many miss that their child
has been given the MMR injection? “At first I thought it was just done by
accident. Now I think it may have to do with Government targets and financial
incentives.” GPs get more money if they vaccinate 95 per cent of the children
in their area but those who fail to meet the target - by even one child - can
lose thousands of pounds a year.
As a result, the doctor claims that bullying tactics have been employed to
encourage parents to get their children inocculated with the triple-vaccine.
“I have been staggered by the lies told to parents to get them to consent to
the MMR vaccine when they express a specific wish for their child to receive
single vaccines instead,” he said. “Shortly after a baby is born parents are
issued with a ‘red book’ which lists the schedule of immunisations their
child is due to receive. “Parents are asked to sign a ‘blanket consent’ for
these vaccinations, but this is not a legally binding document because
consent needs to be informed. “I have heard stories of health visitors trying
to use this to pressurise parents into giving children the MMR vaccine by
saying they have already given their consent for the jab.”
The doctor, who is a specialist in paediatrics, believes that the practice of
giving the MMR jab without parental permission is an abuse of human rights.
“To deliberately give a child a vaccination without their parents’ consent is
medically indefensible particularly when the parents have specifically stated
that they do not want the vaccine,” he said. “It is a blatant abuse of human
rights. More than that, it constitutes actual bodily harm because it involves
puncturing a child’s skin to give the jab.”
Now the doctor is urging parents to be more vigilant and question healthcare
professionals more about what they are administering to their children. A
spokesman for the Department of Health said: “MMR remains the best form of
protection against measles, mumps and rubella. “More than 500 million doses
have been used around the world since the early 1970s and it is recognised by
the World Health Organisation as having an outstanding safety record.”
SECRET trials to test vaccines were carried out on hundreds of vulnerable
children in the UK, according to a report. They allegedly involved orphans,
mentally handicapped children and kids in care in the 1950s and 1960s.
Campaigners say the tests, which in some cases caused brain damage,were often
done without parents' consent. And it is claimed many of the records of the
experiments have disappeared. Olivia Price, of the Vaccine Victims' Support
Group, said the tests involved a whooping cough vaccine which was part of a
jab also covering diphtheria and tetanus.
The claims, revealed in a Radio 4 documentary, are backed by Gordon Stewart,
professor of public health at Glasgow University. He was part of a
government-appointed team which looked at the side-effects of the trials in
He said: 'The severe reactions included convulsions and mental defects.
'Some of the children would scream for two to three days. Some were comatose
and are now, at the age of 40 or 50, brutally defective.'
Alert raised on head injury treatment
James Meikle, health correspondent
Friday October 8, 2004
A routine treatment for patients with head injuries, used for 30 years, may
in fact be slightly increasing their risk of dying, an international trial
involving more than 10,000 patients has revealed.
The results are likely to lead to big changes in the use of corticosteroids
delivered by drip - an anti-inflammatory treatment designed to prevent
potentially lethal swelling of the brain.
The results of a study involving patients from more than 50 countries were
published in the Lancet. Researchers found that 21% of patients treated with
corticosteroids died within two weeks, compared with 18% of those on dummy
treatments. There was no difference in outcome depending on the severity of
injury or how quickly the corticosteroids, delivered via drips, were
The trial was undertaken by the Medical Research Council. Ian Roberts, of the
London School of Tropical Medicine, who was its clinical coordinator, said:
"Obviously, we would have preferred to find out that corticosteroids improve
patients' chances of surviving head injury, but our results are important
because they will improve patient care and protect thousands of future
patients from increased risk of death from corticosteroids."